The Friend of a Friend (FOAF) RDF vocabulary, described using W3C RDF Schema and the Web Ontology Language. Friend of a Friend (FOAF) vocabulary Dave Beckett Nikki Rogers Participants in W3C's Semantic Web Deployment Working Group. Alistair Miles Sean Bechhofer An RDF vocabulary for describing the basic structure and content of concept schemes such as thesauri, classification schemes, subject heading lists, taxonomies, 'folksonomies', other types of controlled vocabulary, and also concept schemes embedded in glossaries and terminologies. The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort . The BRIDG model is an instance of a Domain Analysis Model (DAM). The goal of the BRIDG Model is to produce a shared view of the dynamic and static semantics for the domain of protocol-driven research and its associated regulatory artifacts. This domain of interest is further defined as: Protocol-driven research and its associated regulatory artifacts: i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting. 2012-08-31 en-US SKOS Vocabulary Biomedical Research Integrated Domain Group (BRIDG) Domain Analysis Model Clinical Data Interchange Standards Consortium (CDISC) Health Level Seven (HL7), Regulated Clinical Research Information Management (RCRIM) work group U.S. Food and Drug Administration (FDA) U.S. National Cancer Institute (NCI) BRIDG Semantic Coordination Committee (SCC) Indicates the type of UML aggregation charactersitics an association shows Identifies a constraint that applies within the context of a class Identifies whether a class is considered "abstract" (i.e. not directly instantiatable) Identifies whether a the semantics of a given attribute or association can be determined from other characteristics in the model. (At some point, these derivations might be formally expressed in OWL semantics.) Indicates the role name when traversing the association to the target class The range of skos:altLabel is the class of RDF plain literals. skos:prefLabel, skos:altLabel and skos:hiddenLabel are pairwise disjoint properties. alternative label An alternative lexical label for a resource. Acronyms, abbreviations, spelling variants, and irregular plural/singular forms may be included among the alternative labels for a concept. Mis-spelled terms are normally included as hidden labels (see skos:hiddenLabel). change note A note about a modification to a concept. definition A statement or formal explanation of the meaning of a concept. editorial note A note for an editor, translator or maintainer of the vocabulary. example An example of the use of a concept. The range of skos:hiddenLabel is the class of RDF plain literals. skos:prefLabel, skos:altLabel and skos:hiddenLabel are pairwise disjoint properties. hidden label A lexical label for a resource that should be hidden when generating visual displays of the resource, but should still be accessible to free text search operations. history note A note about the past state/use/meaning of a concept. note A general note, for any purpose. This property may be used directly, or as a super-property for more specific note types. A resource has no more than one value of skos:prefLabel per language tag, and no more than one value of skos:prefLabel without language tag. The range of skos:prefLabel is the class of RDF plain literals. skos:prefLabel, skos:altLabel and skos:hiddenLabel are pairwise disjoint properties. preferred label The preferred lexical label for a resource, in a given language. scope note A note that helps to clarify the meaning and/or the use of a concept. Indicates the class of individuals that are a member of a Group membershipClass unstable composite none shared none performingPerformer be performed by none false performingResearchStaff is a function performed by none false staffedCooperativeGroupMember staffs none false performingResearchStaff is a function performed by none false staffedCooperativeGroupMember staffs none describingAdverseEventSeriousness be described by none describingSafetyReportVersion be described by none triggeredAdverseEventOutcomeAssessment trigger none triggeredCausalAssessment trigger none triggeredPerformedProductInvestigation trigger none assigningPerformedExperimentalUnitAllocation be assigned a subject by none performingExperimentalUnit have been performed by none false assessedPerformedActivity has as subject none false assessingPerformedObservation is the subject of none false performingLaboratory be a function performed by none reportedPerformedObservation report none performedAssessor function as none performedDocumentAuthor function as none producingPerformedSubstanceExtraction be produced by none containedBiologicEntityPart have none groupingBiologicEntityGroup be grouped by none identifyingBiologicEntityIdentifier be identified by none performedAssociatedBiologicEntity function as none performedExperimentalUnit function as none performedSubject function as none scopedAssociatedBiologicEntity scope none containedBiologicEntityGroup be contained in none false containingBiologicEntityGroup contain Indicates that one biologic entity group is composed of other groups. Allows scenarios such as barn with stalls with crates of chickens - different therapies or observations might be made at different levels of grouping. DEFINITION: Indicates that one biologic entity group is composed of other groups. EXAMPLE(S): OTHER NAME(S): NOTE(S): none performedExperimentalUnit function as none performedSubject function as none performedExperimentalUnit function as none evaluatedEvaluatedActivityRelationship evaluate none evaluatedEvaluatedResultRelationship evaluate none performedPerformedSpecimenCollection performs none containedTreatingSite have as a member none false credentialingOrganization is credentialed by none groupedCooperativeGroupMember have as a member none false performingOrganization is a function performed by none containedTreatingSite has as a member none false groupingCooperativeGroup is a member of none false performingOrganization is a function performed by none staffingAdministrativeMemberCRA is staffed by none staffingAdministrativeMemberPI is staffed by none false governedOversightCommittee governs none choiceDefinedCriterionGroupOptionRelationship be an option that can satisfy none choiceDefinedOptionRelationship be an option that can satisfy none componentDefinedCompositionRelationship be the parent of none compositeDefinedCompositionRelationship be the component of none compositeDefinedCriterionGroupCompositionRelationship be the component of none contingentDefinedContingentOnRelationship be a condition for none focusedDefinedObservation be the focal context for none instantiatingPerformedActivity be instantiated by none optionDefinedOptionRelationship be a choice that has as option none prerequisiteDefinedContingentOnRelationship be contingent upon none repeatedDefinedRepeatActivityUntilRule trigger the cessation of none triggeringDefinedRepeatActivityUntilRule be repeated until none usingStudyActivity be used by none choiceDefinedCriterionGroupOptionRelationship be an option that can satisfy none componentDefinedCriterionGroupCompositionRelationship be the parent of none compositeDefinedCriterionGroupCompositionRelationship be the component of none contingentDefinedContingentOnRelationship be a condition for none focusedDefinedObservation be the focal context for none optionDefinedCriterionGroupOptionRelationship be a choice that has as option none repeatedDefinedRepeatActivityUntilRule trigger the cessation of none constrainedPlannedStudySubject constrain none requiringPlannedEligibilityCriterion be required for eligibility for none producedMaterial have produced none false storedSpecimen stores none false attachedDocumentVersion have as an attachment none receivingNotificationReceiver be received by none false focusingDefinedActivity have as focal context none false focusingDefinedCriterionGroup have as focal context Was there a liver chemistry event for the lab samples collected at this visit? DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): none producedDefinedObservationResult result in none referencingDefinedExpressionVariableRelationship be referenced by none choiceDefinedCriterionGroupOptionRelationship be an option that can satisfy none choicePlannedCriterionGroupOptionRelationship be an option that can satisfy none compositeDefinedCriterionGroupCompositionRelationship be the component of none compositePlannedCriterionGroupCompositionRelationship be the component of none contingentDefinedContingentOnRelationship be a condition for none contingentPlannedContingentOnRelationship be a condition for none focusedDefinedObservation be the focal context for none repeatedDefinedRepeatActivityUntilRule trigger the cessation of none repeatedPlannedRepeatActivityUntilRule trigger the cessation of none characterizedStratumGroup characterizes none false transferredProduct is a transfer of none usedDefinedExpressionVariableRelationship use none performedAssessor function as none performedPerformer function as none performedReferenceResult produce none false performingOrganization is a function performed by none false providingProduct provides none false representedProcessor functions as an outlet for none identifyingDocumentIdentifier be identified by none versioningDocumentVersion have as a version none performedNotificationReceiver function as none attachingDefinedNotification be an attachment on none authoringDocumentAuthor is authored by none describingDocumentVersionWorkflowStatus be described by none includingSubmissionUnit be included in none sourceDocumentVersionRelationship be the target for none targetDocumentVersionRelationship be the source for none usingDefinedStudySubjectMilestone be used for none usingPerformedStudySubjectMilestone be used for none assignedSubjectIdentifier assign none false managingOrganization is managed by Indicates the organization that manages the registry. none containedPerformedActivity contain none containedPlannedActivity contain none involvingActivity participate in none false performingProductGroup be a function performed by none overseeingOversightCommittee be overseen by none performedPlannedStudySite plan to function as none performedStudySite function as none performedTreatingSite function as none staffingHealthcareProvider be staffed by none usedHealthcareProviderGroup group staff into none performedAssessor function as none performedDocumentAuthor function as none performedHealthcareProviderGroupMember function as none performedNotificationReceiver function as none performedRegulatoryApplicationSponsor function as none performedStudyLegalSponsor function as none performedStudyPersonnel function as none performedStudySitePersonnel function as none groupedHealthcareProviderGroupMember contains none false performingOrganization is a function performed by none false usingHealthcareFacility is used to group staff for none false groupingHealthcareProviderGroup belongs to none false performingHealthcareProvider is a function performed by none governingRelevantRegulation be governed by none performedAssessor function as none performedCollectingLaboratory function as none performedPerformingLaboratory function as none identifyingMaterialIdentifier be identified by none namingMaterialName is named by none performedSpecimen function as none false producingDefinedMaterialProcessStep have been produced by Indicates that material is produced by a process step. A blood product has anticoagulants added to it to preserve the product A blood product has growth factor added to it to induce cell growth none false producingPerformedMaterialProcessStep have been produced by Indicates that material was produced by a process step. A blood product has anticoagulants added to it to preserve the product A blood product has growth factor added to it to induce cell growth none false performingDocumentAuthor be a function performed by none false performingHealthcareProvider be a function performed by none false performingOrganization be a function performed by none false performingReportSubmitter be a function performed by none false performingStudyPersonnel be a function performed by none false performingStudySitePersonnel be a function performed by none false receivedDefinedNotification be the receiver of none false receivedPerformedNotification be the receiver of none false receivedPlannedNotification be the receiver of none false receivedScheduledNotification be the receiver of none assignedBiologicEntityIdentifier assign none assignedDocumentIdentifier assign none assignedMaterialIdentifier assign none assignedOrganizationIdentifier assign none assignedSubjectIdentifier assign none credentialedCooperativeGroup credential none credentialedQualifiedPerson credential none employedHealthcareProvider be the department for none identifyingOrganizationIdentifier be identified by none locatingServiceDeliveryLocation receive delivery at none managedDonorRegistry manage none managedStudyRegistry manage none performedCooperativeGroup function as none performedCooperativeGroupMember function as none performedDistributor function as none performedHealthcareFacility function as none performedHealthcareProviderGroup function as none performedLaboratory function as none performedNotificationReceiver function as none performedOversightAuthority function as none performedPerformer function as none performedPlannedStudySite plan to function as none performedProcessor function as none performedRegulatoryApplicationSponsor function as none performedReportReceiver function as none performedResearchOrganization function as none performedResourceProvider function as none performedStudyLegalSponsor function as none performedStudySite function as none performedSubject function as none sourceOrganizationRelationship be the target for none supportingOrganizationalContact have communications handled by none targetOrganizationRelationship be the source for none performedStudyOversightAuthority function as none assignedStudySiteOversightStatus assign none governingDataMonitoringCommitteeCharterVersion be governed by none performedAssessor function as none assessingAssessedActivityRelationship be the subject of none commentingPerformedObservation be commented on by none componentPerformedCompositionRelationship be the parent of none compositePerformedCompositionRelationship be the component of none evaluatingEvaluatedActivityRelationship be evaluated by none false instantiatedScheduledActivity instantiate none triggeringObservationResultActionTakenRelationship be triggered by none originalPerformedClinicalResult be converted from false targetBiomarkerCode Genetic Marker A coded value specifying a variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. This is the focus of an observation. Biomarkers include but are not limited to such phenotypic parameters as specific enzyme or hormone concentration For an observation with a nameCode of "Determine the Allele for the HLA-A Locus on Chromosome 6" For an observation with a nameCode of "Determine the variant nucleotide for Single Nucleotide Polymorphism RS110789" presence or absence of biological substance. specific gene phenotype the observation result might have a targetBiomarkerCode of "HLA-A" and a value of "HLA-A*01:01:01" (the specific allele) the observation result might have a targetBiomarkerCode of "Rs110789" and a value of "C" (cytosine the specific nucleotide that is variant) There is no associated 'approach' for a Biomarker, as there is for an anatomic site. In the context of Bone Marrow Transplantation, the bodily substance that is collected to determine the Biomarker (the HLA Alleles) is typically blood or saliva. Thus, the thing that is collected is the typeCode of the Material that is collected via a PerformedSpecimenCollection. The attribute 'targetBiomarkerCode' was chosen as inclusive of 'targetGeneticMarkerCode', which is more specific to the Bone Marrow Transplantation domain. However, the Life Sciences Domain Analysis Model is using Biomarker as the focus of their Genomic Analysis, and thus this broader definition was chosen to facilitate that alignment. none false componentPerformedActivity is the parent of none false compositePerformedActivity is the component of none addressingPerformedDiagnosisProcedureRelationship be addressed by none false transformedPerformedDiagnosis be transformed into none transformingPerformedDiagnosis be transformed from none false addressedPerformedDiagnosis addresses none false addressingPerformedProcedure is addressed by false primaryIndicator Specifies whether this is the main or principal diagnosis addressed by a procedure. none producedMaterial have produced none addressingPerformedSubstanceAdministration be addressed by none receivingNotificationReceiver be received by none assessedAssessedActivityRelationship have as subject none assessedAssessedResultRelationship have as subject none resultedPerformedObservationResult result in none assessingAssessedResultRelationship be the subject of none describingReportVersion be described by none describingTargetAnatomicSite be described by none evaluatingEvaluatedResultRelationship be evaluated by none inferredPerformedObservationResult infer none recordedPerformedProcedure result in recording none triggeredObservationResultActionTakenRelationship trigger none addressedPerformedDiagnosisProcedureRelationship address false nonReasonCode A coded value specifying the motivation, cause or rationale that is explicitly NOT why an activity occurred. none reportingSafetyReportVersion be reported as a prior therapy in none usedConcomitantAgent use none describingSafetyReportVersion be described by none triggeredPerformedProductInvestigation trigger none false implementingStudySitePersonnel have management action implemented by none false managingStudyResearchCoordinator have management action determined by none false performingCollectingLaboratory be performed by none producedSpecimen result in none assignedDocumentIdentifier result in none false authorizingStudySiteResearchCoordinator be authorized by none producedSubstanceExtractionAdministrationRelationship be using a substance produced by none false producedBiologic produces none usedSubstanceExtractionAdministrationRelationship be producing a substance later used in none performedPerformedObservation perform none performedReferenceResult produce none performedHealthcareProvider function as none performedOrganizationalContact function as none performedPerformer function as none performedQualifiedPerson function as none performedReportReceiver function as none performedResearchStaff function as none performedResourceProvider function as none containedPlace contain none locatedPerformedActivity be the location for none locatedQualifiedPerson be the location in which the qualification is granted for none locatingServiceDeliveryLocation be the location for none performedProcessingSite function as none choicePlannedCriterionGroupOptionRelationship be an option that can satisfy none choicePlannedOptionRelationship be an option that can satisfy none componentPlannedCompositionRelationship be the parent of none compositePlannedCompositionRelationship be the component of none compositePlannedCriterionGroupCompositionRelationship be the component of none containingArm occur in none contingentPlannedContingentOnRelationship be a condition for none instantiatingPerformedActivity be instantiated by none instantiatingScheduledActivity be instantiated by none false locatingServiceDeliveryLocation take place in none optionPlannedOptionRelationship be a choice that has as option none prerequisitePlannedContingentOnRelationship be contingent upon none repeatedPlannedRepeatActivityUntilRule trigger the cessation of none triggeringPlannedRepeatActivityUntilRule be repeated until none choicePlannedCriterionGroupOptionRelationship be an option that can satisfy none componentPlannedCriterionGroupCompositionRelationship be the parent of none compositePlannedCriterionGroupCompositionRelationship be the component of none contingentPlannedContingentOnRelationship be a condition for none optionPlannedCriterionGroupOptionRelationship be a choice that has as option none repeatedPlannedRepeatActivityUntilRule trigger the cessation of none false requiredDefinedEligibilityCriterionAnswer requires for eligibility none receivingNotificationReceiver be received by none definedRandomizationBookEntry defines none supportsStudySitePersonnel have a role planned to be performed by none false constrainingDefinedEligibilityCriterion be constrained by Indicates the criteria a particular PlannedStudySubject is expected to adhere to. none false plannedForStudyProtocolVersion participates in Indicates the types of StudySubjects intended to participate in the StudyProtocolVersion. ActualIndicator should be set to 'false' for the Entity that is the subject none false fabricatingProduct fabricates none false operatingProcessor manufactures for none false performingPlace is a function performed by none operatedProcessingSite manufacture at none producedProcessedProduct produces none representingDistributor have as an outlet none describingSubmission be the subject for none fabricatedProcessingSite be fabricated by shared groupingProductGroup be grouped by none involvingPerformedProductProblemDiscovery be the focus of none performedConcomitantAgent function as none performedExperimentalUnit function as none performedStudyAgent function as none performedSubject function as none producingProcessedProduct be produced by none providedDistributor be provided by none sourceProductRelationship be the target for none targetProductRelationship be the source for none transferringDefinedStudyAgentTransfer be transferred during none transferringPerformedStudyAgentTransfer be transferred during none usingDefinedProcedure be used during none usingPerformedProcedure be used during shared false groupedProduct groups none performedExperimentalUnit function as none referencingPerformedClinicalResult be referenced by composite groupedSubmission groups none submittedSubmission submits none evaluatedSubmission evaluates none approvedMaterialName approve none locatingPlace have jurisdiction over none performedRegulatoryAssessment perform none false governedInterventionalStudyProtocolVersion governs none performedNotificationReceiver function as none receivingReportReceiver be received by none staffingResearchStaff be staffed by none performedAdministrativeMemberCRA function as none performedAdministrativeMemberPI function as none performedAssessor function as none performedDocumentAuthor function as none performedReportSubmitter function as none performedStudyPersonnel function as none performedStudySitePersonnel function as none usingStudyResource be used for none usingStudySiteResource be used for none providedResource provides composite groupedSubmissionUnit groups none commentingPerformedObservation be commented on by none false reportedPerformedProcedure report as prior therapies none submittingReportSubmitter is submitted by none false instantiatedPlannedActivity instantiates none instantiatingPerformedActivity be instantiated by none receivingNotificationReceiver be received by false activeIngredientDose The quantity of active ingredient anticipated to be administered. 5 mg This is intended to be a subject-specific quantity. DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or relative terms (e.g., mg or mg/kg). ScheduledSubstanceAdministration.activeIngredientDose and PerformedSubstanceAdministration.productDose must contain a dose expressed in absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was expressed in relative terms (e.g., mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the DefinedDoseExpressionVariableRelationship. none destinedPerformedProductTransport be the destination for none locatedPlannedActivity be the location for none originatedPerformedProductTransport be the origin of none performedExperimentalUnit function as none performedSubject function as none producingDefinedSpecimenCollection be a result of none storingDefinedSpecimenStorage be stored during none versioningStatisticalAnalysisPlanVersion has as a version composite containedGeneralStatisticalConsideration have none createdStatisticalAnalysisPlanDocumentVersion be used to create none describingStatisticalAnalysisPlanVersionStatus be described by shared includedSampleSizeConsideration include none influencingDataMonitoringCommitteeCharterVersion be influenced by none sourceStatisticalAnalysisPlanVersionModificationSummary be the target for none targetStatisticalAnalysisPlanVersionModificationSummary be the source for none false describedStatisticalAnalysisPlanVersion describes Identifies the statuses at different points in time for a particular version of a statistical analysis plan. none randomizingRandomizationBookEntry be randomized by none usingPlannedActivity be used as none describingStudyOverallStatus be described by none describingStudyRecruitmentStatus be described by none executingStudySite be executed at none overseeingStudyOversightAuthority be overseen by none performingStudyPersonnel have a role performed by none referencingReferenceToStudyResults have results referenced in none usedStudyResource use none authorizedPerformedProtocolDeviation authorize none measuringStudyOutcomeMeasure is measured by none performedNotificationReceiver function as none false performingHealthcareProvider be a function performed by Indicates that the StudyPersonnel role is being fulfilled by a HealthcareProvider none accompaniedCompanionStudyRelationship be a companion of none addressingStudySpecificStatisticalAnalysisPlan have statistical needs addressed by none instantiatedStudyExecution be the plan for none integratingIntegratedStatisticalAnalysisPlan have data integrated from none representingStudyProtocolDocument be represented in none versioningStudyProtocolVersion has as a version none false containedStudyProtocolVersion contains none accompanyingCompanionStudyRelationship have as a companion none addressingStatisticalAnalysisPlanVersion have statistical needs addressed by none containingStudyProtocolDocumentVersion be the contents of none describedStratumGroup define none evaluatedStudyAgent be evaluating none executedPerformedActivity be executed by none executingPlannedStudySite be planned to be executed at none executingStudySiteProtocolVersionRelationship be executed at none intendedPlannedStudySubject is participated in by none investigatedStudyCondition focus on none involvedStudyObjective aim to achieve none overseeingStudyOversightAuthority be overseen by none performedStudyPersonnel have a role performed by none referencingStudyReference refer to none sponsoringStudyLegalSponsor be the responsibility of none subdividingArm be divided into none subdividingEpoch be divided into none usedStudyActivity use none usedStudyResource use none assignedDocumentIdentifier assign none managedPerformedProtocolDeviation determine the management action for none describingStudySiteRecruitmentStatus be described by none executedStudySiteProtocolVersionRelationship execute none overseeingOversightCommittee be overseen by none performedPerformedAdministrativeActivity perform none performingStudySitePersonnel have a role performed by none usedStudySiteResource use none implementedPerformedProtocolDeviation implement the management action for none performedNotificationReceiver function as none false performingHealthcareProvider be a function performed by Indicates that the StudySitePersonnel role is being fulfilled by a HealthcareProvider. none assignedStudySubjectProtocolVersionRelationship be the assigned version for none describingStudySiteOversightStatus be described by none false describedStudySite describes Indicates the point-in-time recruitment status of a study from the perspective of the study site. none authorizedPerformedStudyAgentTransfer authorize none false usedResource uses DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S): none false usingStudySite is used at Indicates resources intended to be or actually consumed by a particular study site. none assignedStudySubjectProtocolVersionRelationship be assigned to none describingStudySubjectExperienceDocumentVersion have experience described by none false describedStudySubject describes experience of Indicates the subject whose experience is recounted in the study subject experience document. none identifyingSubjectIdentifier be identified by none involvingActivity participate in none performedAssessor function as none performedDocumentAuthor function as none false performingBiologicEntityGroup be a function performed by Indicates that a particular group of biologic entities is the subject of a particular activity. Used when the activity is done to the group as a whole rather than individuals. E.g. drugs in shared feed, spraying, group therapy, etc. none false performingOrganization be a function performed by Indicates that the Organization is participating as the subject of an activity. Audit none false assigningDonorRegistry be assigned by Indicates the donor registry that assigned the identifer. composite groupedReviewableUnit group composite groupedSubmissionUnit group none false producingPerformedSubstanceExtraction uses a substance produced by none false usingPerformedSubstanceAdministration be producing a substance later used in none assignedDocumentIdentifier assign none assignedOrganizationIdentifier assign none assignedSubjectIdentifier assign none false describedPerformedObservationResult described Indicates result being described by a particular site. false primaryIndicator Specifies whether this is the main or principal site. none false containingCooperativeGroup be a member of none false containingCooperativeGroupMember be a member of none false performingHealthcareFacility is a function performed by Represents associations between BRIDG classes Represents attributes of BRIDG classes Grouper for attribute and association for situations where either may apply. has broader match skos:broadMatch is used to state a hierarchical mapping link between two conceptual resources in different concept schemes. Broader concepts are typically rendered as parents in a concept hierarchy (tree). has broader Relates a concept to a concept that is more general in meaning. By convention, skos:broader is only used to assert an immediate (i.e. direct) hierarchical link between two conceptual resources. has broader transitive skos:broaderTransitive is a transitive superproperty of skos:broader. By convention, skos:broaderTransitive is not used to make assertions. Rather, the properties can be used to draw inferences about the transitive closure of the hierarchical relation, which is useful e.g. when implementing a simple query expansion algorithm in a search application. has close match skos:closeMatch is used to link two concepts that are sufficiently similar that they can be used interchangeably in some information retrieval applications. In order to avoid the possibility of "compound errors" when combining mappings across more than two concept schemes, skos:closeMatch is not declared to be a transitive property. skos:exactMatch is disjoint with each of the properties skos:broadMatch and skos:relatedMatch. has exact match skos:exactMatch is used to link two concepts, indicating a high degree of confidence that the concepts can be used interchangeably across a wide range of information retrieval applications. skos:exactMatch is a transitive property, and is a sub-property of skos:closeMatch. has top concept Relates, by convention, a concept scheme to a concept which is topmost in the broader/narrower concept hierarchies for that scheme, providing an entry point to these hierarchies. is in scheme Relates a resource (for example a concept) to a concept scheme in which it is included. A concept may be a member of more than one concept scheme. These concept mapping relations mirror semantic relations, and the data model defined below is similar (with the exception of skos:exactMatch) to the data model defined for semantic relations. A distinct vocabulary is provided for concept mapping relations, to provide a convenient way to differentiate links within a concept scheme from links between concept schemes. However, this pattern of usage is not a formal requirement of the SKOS data model, and relies on informal definitions of best practice. is in mapping relation with Relates two concepts coming, by convention, from different schemes, and that have comparable meanings has member Relates a collection to one of its members. For any resource, every item in the list given as the value of the skos:memberList property is also a value of the skos:member property. has member list Relates an ordered collection to the RDF list containing its members. has narrower match skos:narrowMatch is used to state a hierarchical mapping link between two conceptual resources in different concept schemes. Narrower concepts are typically rendered as children in a concept hierarchy (tree). has narrower Relates a concept to a concept that is more specific in meaning. By convention, skos:broader is only used to assert an immediate (i.e. direct) hierarchical link between two conceptual resources. has narrower transitive skos:narrowerTransitive is a transitive superproperty of skos:narrower. By convention, skos:narrowerTransitive is not used to make assertions. Rather, the properties can be used to draw inferences about the transitive closure of the hierarchical relation, which is useful e.g. when implementing a simple query expansion algorithm in a search application. skos:related is disjoint with skos:broaderTransitive has related Relates a concept to a concept with which there is an associative semantic relationship. has related match skos:relatedMatch is used to state an associative mapping link between two conceptual resources in different concept schemes. is in semantic relation with Links a concept to a concept related by meaning. This property should not be used directly, but as a super-property for all properties denoting a relationship of meaning between concepts. is top concept in scheme Relates a concept to the concept scheme that it is a top level concept of. Indicates an account held by this agent. account testing Indicates a homepage of the service provide for this online account. account service homepage testing A location that something is based near, for some broadly human notion of near. based near testing A current project this person works on. current project testing A depiction of some thing. depiction testing A thing depicted in this representation. depicts testing The underlying or 'focal' entity associated with some SKOS-described concept. focus testing An organization funding a project or person. funded by archaic Indicates an account held by this agent. account archaic A homepage for some thing. homepage stable An image that can be used to represent some thing (ie. those depictions which are particularly representative of something, eg. one's photo on a homepage). image testing A page about a topic of interest to this person. interest testing A document that this thing is the primary topic of. is primary topic of stable A person known by this person (indicating some level of reciprocated interaction between the parties). knows stable A logo representing some thing. logo testing Something that was made by this agent. made stable An agent that made this thing. maker stable A personal mailbox, ie. an Internet mailbox associated with exactly one owner, the first owner of this mailbox. This is a 'static inverse functional property', in that there is (across time and change) at most one individual that ever has any particular value for foaf:mbox. personal mailbox stable Indicates a member of a Group member stable An OpenID for an Agent. openid testing A page or document about this thing. page stable A project this person has previously worked on. past project testing A phone, specified using fully qualified tel: URI scheme (refs: http://www.w3.org/Addressing/schemes.html#tel). phone testing The primary topic of some page or document. primary topic stable A link to the publications of this person. publications testing A homepage of a school attended by the person. schoolHomepage testing A theme. theme archaic A derived thumbnail image. thumbnail testing A tipjar document for this agent, describing means for payment and reward. tipjar testing A topic of some page or document. topic testing A thing of interest to this person. topic_interest testing A weblog of some thing (whether person, group, company etc.). weblog stable A work info homepage of some person; a page about their work for some organization. work info homepage testing A workplace homepage of some person; the homepage of an organization they work for. workplace homepage testing notation A notation, also known as classification code, is a string of characters such as "T58.5" or "303.4833" used to uniquely identify a concept within the scope of a given concept scheme. By convention, skos:notation is used with a typed literal in the object position of the triple. Indicates the name (identifier) associated with this online account. account name testing The age in years of some agent. age unstable The birthday of this Agent, represented in mm-dd string form, eg. '12-31'. birthday unstable A checksum for the DNA of some thing. Joke. DNA checksum archaic The family name of some person. familyName testing The family name of some person. family_name archaic The first name of a person. firstName testing A textual geekcode for this person, see http://www.geekcode.com/geek.html geekcode archaic The gender of this Agent (typically but not necessarily 'male' or 'female'). gender testing The given name of some person. Given name testing The given name of some person. Given name archaic The last name of a person. lastName testing A Myers Briggs (MBTI) personality classification. myersBriggs testing A short informal nickname characterising an agent (includes login identifiers, IRC and other chat nicknames). nickname testing A .plan comment, in the tradition of finger and '.plan' files. plan testing A sha1sum hash, in hex. sha1sum (hex) unstable A Skype ID Skype ID testing A string expressing what the user is happy for the general public (normally) to know about their current activity. status unstable The surname of some person. Surname archaic Title (Mr, Mrs, Ms, Dr. etc) title testing dcam:VocabularyEncodingScheme 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 1 1 1 1 0 0 0 0 0 1 1 1 1 1 0 1 0 0 0 0 1 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 1 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 0 0 1 1 0 1 1 1 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 0 0 0 1 0 0 0 0 0 1 1 1 1 1 0 0 1 0 0 0 1 1 1 1 1 1 0 0 1 0 0 1 1 1 1 0 0 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 0 1 0 1 1 1 1 1 1 1 1 1 1 1 1 0 1 bridg:DataEntity Abstract construct collecting all BRIDG classes together 0 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 0 0 0 1 1 1 1 1 0 0 0 1 1 1 1 1 0 0 1 0 0 0 0 0 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 0 0 0 0 0 1 1 1 1 1 1 0 0 1 0 0 1 0 1 0 1 1 1 1 0 0 0 1 1 1 0 1 1 0 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 0 0 1 1 1 1 0 0 0 0 0 0 0 1 1 1 1 1 1 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 1 1 1 0 1 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 1 1 0 0 0 0 0 1 1 1 1 1 0 0 0 1 0 0 0 0 1 1 1 1 1 1 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 0 1 1 1 1 0 0 0 1 1 1 1 1 0 1 1 0 0 0 0 1 1 1 1 0 0 0 0 0 1 0 0 1 1 1 1 1 1 1 1 0 0 0 1 1 1 1 1 1 1 0 0 0 1 1 1 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 0 1 1 0 0 1 1 1 0 0 0 0 0 0 1 1 1 1 1 1 0 0 0 0 0 0 1 0 0 0 0 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 0 1 1 1 1 1 1 0 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 1 1 0 0 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 0 1 0 0 1 1 1 1 0 0 1 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 0 0 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 1 0 0 0 1 1 1 1 1 1 0 1 1 0 1 1 1 1 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 0 1 1 0 0 0 0 0 0 0 1 1 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 1 1 1 0 0 0 0 0 1 1 1 1 1 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 0 1 1 1 0 0 1 1 0 1 0 0 1 1 0 0 0 1 1 1 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 0 0 1 0 0 1 1 0 0 0 0 0 0 0 1 1 1 1 1 1 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 1 1 1 1 0 1 0 1 0 0 0 0 1 1 1 1 0 0 0 0 0 0 0 1 1 1 1 1 1 1 0 0 1 0 1 0 0 0 1 1 1 1 1 0 0 0 0 0 0 0 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 0 0 1 0 0 0 0 0 0 1 1 1 1 1 1 1 1 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 1 1 1 1 1 0 0 1 0 0 0 0 0 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 0 0 0 0 0 1 1 1 1 1 1 1 1 0 0 0 1 1 1 1 0 0 1 1 1 1 1 0 0 0 1 0 0 0 1 1 1 1 1 1 1 0 1 0 0 0 0 1 1 1 1 1 0 1 0 1 1 0 0 1 1 0 1 1 1 1 1 1 1 1 1 0 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 0 1 0 0 0 1 1 1 0 0 0 0 0 1 1 0 1 1 1 1 1 1 1 1 0 1 0 0 0 1 0 1 1 1 1 1 1 1 1 0 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 0 0 0 0 1 0 1 1 1 1 1 1 0 1 1 0 0 1 1 0 0 0 1 1 1 1 0 1 0 0 1 0 0 0 0 1 1 1 1 1 1 1 1 0 0 0 0 0 1 1 0 0 1 1 1 1 0 0 0 0 1 1 1 1 1 1 0 1 1 1 1 0 0 0 0 0 1 1 1 0 1 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 1 1 1 1 1 1 0 0 0 0 1 1 0 0 0 0 1 1 1 1 1 1 1 0 1 1 0 0 0 0 0 0 1 0 1 1 1 1 0 1 1 0 0 1 0 0 0 0 0 1 1 1 1 1 1 1 0 0 0 1 1 0 1 0 1 0 0 0 0 0 0 0 0 1 1 1 1 1 0 0 0 0 1 0 0 0 0 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 0 0 1 1 0 0 1 1 1 1 1 1 0 0 1 1 1 1 1 1 0 0 0 1 1 1 0 1 0 1 1 1 1 0 0 1 0 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 0 1 0 1 1 1 0 0 0 0 0 1 0 0 0 0 1 1 1 0 0 1 1 0 0 0 0 1 1 1 1 1 0 1 1 0 1 1 1 0 1 0 0 0 0 1 1 1 1 1 0 0 0 0 1 0 1 1 1 1 1 1 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 0 0 0 0 0 1 1 1 1 1 1 1 0 0 0 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 1 1 1 1 0 0 0 0 1 0 1 1 1 1 1 0 0 0 0 1 1 1 0 0 0 0 1 0 0 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 0 1 0 1 0 0 0 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 0 0 0 1 1 1 1 1 0 0 1 1 1 1 0 1 1 1 1 1 1 0 0 0 0 0 0 1 1 1 1 1 1 1 1 0 1 1 1 bridg:SubDomain Abstract construct collecting all BRIDG packages together 0 0 0 0 0 0 0 0 0 1 1 1 1 1 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 1 0 0 0 1 0 0 0 1 0 1 1 1 1 1 1 1 1 0 0 0 1 0 0 1 1 1 1 1 0 1 0 0 1 1 1 1 0 1 0 0 0 0 1 0 1 0 1 1 1 0 0 1 1 1 1 dt:AD dt:ANY dt:BAG_AD dt:BAG_TEL dt:BL dt:CD dt:DSET_CD dt:DSET_EN dt:DSET_II dt:DSET_ON dt:DSET_SC dt:DSET_ST dt:ED dt:EXPR_PQ dt:HL7AbstractDatatype dt:II dt:INT.NONNEG dt:INT.POS dt:IVL_EXPR_TS.DATETIME dt:IVL_INT dt:IVL_TS.DATE dt:IVL_TS.DATE.FULL dt:IVL_TS.DATETIME dt:OID dt:PQ dt:PQ.TIME dt:REAL dt:RTO_INT.NONNEG_INT.POS dt:RTO_INT.NONNEG_PQ.TIME dt:RTO_PQ_PQ dt:RTO_PQ_PQ.TIME dt:ST dt:ST.SIMPLE dt:TEL dt:TEL.URL dt:TN dt:TS.DATE.FULL dt:TS.DATETIME dt:URG_INT.NONNEG dt:URG_INT.POS dt:URG_PQ dt:URG_PQ.TIME rdf:List rdfs:Class owl:Thing Thing Spatial Thing skos:Collection Collection A meaningful collection of concepts. Labelled collections can be used where you would like a set of concepts to be displayed under a 'node label' in the hierarchy. skos:Concept Concept Concept An idea or notion; a unit of thought. skos:ConceptScheme Concept Scheme A set of concepts, optionally including statements about semantic relationships between those concepts. Thesauri, classification schemes, subject heading lists, taxonomies, 'folksonomies', and other types of controlled vocabulary are all examples of concept schemes. Concept schemes are also embedded in glossaries and terminologies. A concept scheme may be defined to include concepts from different sources. skos:OrderedCollection Ordered Collection An ordered collection of concepts, where both the grouping and the ordering are meaningful. Ordered collections can be used where you would like a set of concepts to be displayed in a specific order, and optionally under a 'node label'. foaf:Agent An agent (eg. person, group, software or physical artifact). Agent stable foaf:Document A document. Document stable foaf:Group A class of Agents. Group stable foaf:Image An image. Image stable foaf:LabelProperty A foaf:LabelProperty is any RDF property with texual values that serve as labels. Label Property unstable foaf:OnlineAccount An online account. Online Account testing foaf:OnlineChatAccount An online chat account. Online Chat Account unstable foaf:OnlineEcommerceAccount An online e-commerce account. Online E-commerce Account unstable foaf:OnlineGamingAccount An online gaming account. Online Gaming Account unstable foaf:Organization An organization. Organization stable foaf:Person A person. Person stable foaf:PersonalProfileDocument A personal profile RDF document. PersonalProfileDocument testing foaf:Project A project (a collective endeavour of some kind). Project testing 2012-06-14 DCMI Metadata Terms - other 2008-01-14 2008-01-14 2008-01-14 2000-07-11 2000-07-11 The set of classes specified by the DCMI Type Vocabulary, used to categorize the nature or genre of the resource. DCMI Type Vocabulary 2000-07-11 The set of conceptual resources specified by the Dewey Decimal Classification. DDC 2008-01-14 2008-01-14 2000-07-11 The set of media types specified by the Internet Assigned Numbers Authority. IMT 2000-07-11 2000-07-11 2008-01-14 2008-01-14 2000-07-11 The set of conceptual resources specified by the Library of Congress Classification. LCC 2000-07-11 The set of labeled concepts specified by the Library of Congress Subject Headings. LCSH 2008-01-14 2008-01-14 2008-01-14 2008-01-14 2000-07-11 The set of labeled concepts specified by the Medical Subject Headings. MeSH 2008-01-14 2008-01-14 2008-01-14 2008-01-14 2005-06-13 The set of conceptual resources specified by the National Library of Medicine Classification. NLM 2000-07-11 2008-01-14 2008-01-14 2008-01-14 2000-07-11 2008-01-14 2008-01-14 2000-07-11 2002-07-13 2008-01-14 2010-10-11 2008-01-14 2008-01-14 2008-01-14 2000-07-11 The set of places specified by the Getty Thesaurus of Geographic Names. TGN 2000-07-11 The set of conceptual resources specified by the Universal Decimal Classification. UDC 2000-07-11 2000-07-11 2000-07-11 2003-02-15 2005-06-13 2005-06-13 2005-06-13 2000-07-11 2001-05-21 2000-07-11 2003-02-15 2001-05-21 2008-01-14 2008-01-14 2000-07-11 2008-01-14 2008-01-14 2002-07-13 2002-07-13 2002-07-13 2008-01-14 2002-07-13 2000-07-11 2008-01-14 2000-07-11 2000-07-11 2000-07-11 2008-01-14 2005-06-13 Instructional Method typically includes ways of presenting instructional materials or conducting instructional activities, patterns of learner-to-learner and learner-to-instructor interactions, and mechanisms by which group and individual levels of learning are measured. Instructional methods include all aspects of the instruction and learning processes from planning and implementation through evaluation and feedback. A process, used to engender knowledge, attitudes and skills, that the described resource is designed to support. Instructional Method 2000-07-11 2000-07-11 2000-07-11 2000-07-11 2000-07-11 2000-07-11 2000-07-11 2008-01-14 2004-06-14 2001-05-21 2000-07-11 2000-07-11 2004-09-20 The statement may include a description of any changes successive custodians made to the resource. A statement of any changes in ownership and custody of the resource since its creation that are significant for its authenticity, integrity, and interpretation. Provenance 2008-01-14 2000-07-11 2008-01-14 2000-07-11 2000-07-11 2008-01-14 2004-06-14 Recommended practice is to refer to the rights holder with a URI. If this is not possible or feasible, a literal value that identifies the rights holder may be provided. A person or organization owning or managing rights over the resource. Rights Holder 2008-01-14 2000-07-11 2008-01-14 2000-07-11 2000-07-11 2008-01-14 2008-01-14 2000-07-11 in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in R_Product ExperimentalUnit ExperimentalUnit Activity Subject Arm HCT? NST / RIC preparative regimen: s for the supplemental intravenous immunoglobulin therapy: in IndividualCaseSafetyReport in IndividualCaseSafetyReport AdverseEvent AdverseEvent View Description: The Adverse Event sub-domain is intended for those involved in safety related activities; such as detection, evaluation, follow-up and reporting. This includes safety issues involving people or products. It also includes activities during or after a research protocol. View Description: This view represents the Adverse Event (AE) semantics from the Adverse Event Domain Analysis Model, which was developed by representatives from several AE projects: HL7's Individual Case Safety Report (ICSR), CDISC's Study Data Tabulation Model for Human Subjects (SDTM), NCI's Cancer AE Reporting System (caAERS) and Adverse Event Expedited Reporting System (AdEERS), and the Federal Adverse Event Task Force (FAET). The AE model introduced several new concept areas pertaining to devices, animals, and products. There are 2 instance diagrams that illustrate the use of this view. Adverse Event Sub-Domain in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport ArmIntervention ArmIntervention Arm Arm Arm Study StudyProtocolVersion in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport PerformedObservationResult PerformedObservation in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport AssociatedBiologicEntity Device HealthcareProvider OversightCommittee ResearchStaff Subject in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport BiologicEntity BiologicEntity in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport View Description: This View shows the complete BRIDG Model (current Release) and specifically shows, for each class where it's applicable, the complete set of attributes for the class, partitioning the attributes as to whether they are "local" to the class or inherited from the class' super-type hierarchy. BRIDG Domain Analysis Model in R_Product in R_Product in R_Product choice box.determinerCode Universal in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport when date is not known but death is known in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in E_Organization informational in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product s s of Monetary or Material Support choice box.determinerCode BiologicEntity in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport Organization Organization IdentifiedEntity BiologicEntity BiologicEntity CRID Universal Recipient ID in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport BiologicEntity BiologicEntity in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport AdverseEvent Laboratory External Registry: We need an ontology of organization types. For Example, government, academic, pharmaceutical etc.. View Description: The Common sub-domain represents the semantics that are common to all (or most) of the other sub-domains. For example, it includes semantics for such things as people, organizations, places and materials. Common Sub-Domain StudyProtocolVersion StudyProtocol Product PerformedProcedure in R_Product StatisticalAnalysisPlanVersion in R_Product in R_Product CML: Part 1 of 2.What type of treatment did the recipient receive prior to the hematopoietic stem cell transplantation (HSCT? CML: Part 1 of 2.Specify the other type of therapy that the recipient received prior to this hematopoietic stem cell transplantation (HSCT: HSCT therapy? s given for central nervous system: s were used? in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in R_Product meddraTerm otherTerm in R_Product DefinedActivity DefinedActivity New content DefinedActivity DefinedActivity DefinedCriterionGroup DefinedObservationResult DefinedActivity DefinedCriterionGroup DefinedObservationResult DefinedCriterionGroup New content DefinedCriterionGroup DefinedActivity DefinedCriterionGroup DefinedObservationResult DefinedObservation DefinedSubstanceAdministration DefinedObservationResult New content DefinedObservation DefinedObservation e.g. informed consent s s meddraTerm otherTerm DefinedActivity DefinedActivity Product Product DefinedActivity DefinedActivity DefinedCriterionGroup DefinedObservationResult Specimen DocumentVersion per the protocol? per the protocol? First In Human dose allowed per the protocol? per the protocol? in R_Product in R_Product in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport DocumentVersion AssociatedBiologicEntity HealthcareProvider ResearchStaff Subject in IndividualCaseSafetyReport in IndividualCaseSafetyReport Organization Organization StudyRegistry StudyRegistry SystemOfRecord Document Document Document in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport PerformedStudyAdministrativeActivity in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport Document Document StudyRelationship in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport DocumentVersion DocumentVersion in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport DocumentWorkflowStatus DocumentVersion in R_Product in R_Product in R_Product Epoch StudyProtocolVersion in IndividualCaseSafetyReport in IndividualCaseSafetyReport PerformedActivity CausalAssessment in IndividualCaseSafetyReport PerformedObservationResult CausalAssessment Arm BiologicEntity BiologicEntity BiologicEntityGroup BiologicEntityPart BiologicEntityPart Product Product BiologicSpecimen Specimen in R_Product s of Monetary or Material Support StatisticalAnalysisPlanVersion Organization Organization Person in IndividualCaseSafetyReport HealthcareFacility in IndividualCaseSafetyReport StudyProtocol Organization in R_Product in R_Specimen universal in R_Specimen universal choice box.determinerCode Universal in R_Product in R_Product s product name(s EudraVigilance Substance Code in R_Specimen universal in R_Product in R_Specimen universal in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product Organization Material CBU ID: in R_Product in R_Product in R_Product in R_Product in R_Specimen universal in R_Product in R_Product RegulatoryAuthority s product name(s s of hematopoietic growth factor or cytokine agents given: in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product Material s of Monetary or Material Support PerformedActivity PerformedActivity PerformedObservationResult in R_Product in E_Organization informational in IndividualCaseSafetyReport in R_Product in R_Product in IndividualCaseSafetyReport Universal Universal_COCT_RM_090000UV in IndividualCaseSafetyReport in R_Product National Competent Authority HSCT : Part 1 of 4.If the institution where previous HSCT was performed is different from the current HSCT, what is the name of the institution? in R_Product in IndividualCaseSafetyReport in R_Product in R_Product s s of Monetary or Material Support member state HSCT : Part 1 of 4.If the institution where previous HSCT was performed is different from the current HSCT, what is the city where the institution is located? HSCT : Part 1 of 4.If the institution where previous HSCT was performed is different from the current HSCT, what is the country where the institution is located? HSCT : Part 1 of 4.If the institution where previous HSCT was performed is different from the current HSCT, what is the state where the institution is located? in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport Organization SystemOfRecord IdentifiedEntity Organization CIC Number in R_Product in IndividualCaseSafetyReport in R_Product in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport Universal in R_Product in IndividualCaseSafetyReport in R_Product Universal_COCT_RM_150000UV OrganizationalGroup Organization OrganizationalGroupRelationship OrganizationalRelationship Organization Independent Ethics Committee Applicant Type Universal_COCT_RM_150000UV in R_Product in R_Product in E_Organization informational in IndividualCaseSafetyReport in R_Product Person in E_Organization informational in IndividualCaseSafetyReport in R_Product Organization in E_Organization informational in IndividualCaseSafetyReport in R_Product Organization Organization HealthcareFacility StudySite StudySite StudySite in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product PerformedActivity Epoch HSCT : Part 1 of 4.Date of the most recent previous HSCT: HSCT : Part 1 of 4.Date of hematopoietic stem cell transplantation (HSCT for which this form is being completed: specimen collection date. in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in R_Specimen universal in R_Product DefinedActivity PlannedActivity Place Chronic SLE, what was the C4 test result? NAT for human immunodeficiency virus(HIV-1 performed; specify results in IndividualCaseSafetyReport in IndividualCaseSafetyReport StudyProtocolVersion StudySite New content - variance type needed for RIM mapping PerformedClinicalResult ReferenceResult kappa finding? PerformedActivity Karnofsky Lansky CML: Part 1 of 2.If the CML was in hematologic complete remission, what was the disease status before treatment? CML: Part 1 of 2.What was the phase of the CML at the time of transplantation? AML or acute nonlymphocytic leukemia (ANLL at the time of transplantation? ALL at the time of transplantation? Arm in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport PerformedActivity SafetyReportVersion in IndividualCaseSafetyReport SLE biopsy type? s were used to evaluate the status? in IndividualCaseSafetyReport PerformingLaboratory Assessor in R_Product in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport PerformedObservationResult PerformedObservationResult PerformedObservation SLE, what was the involved organ or clinical problem? SLE involvement: SOC in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport NAT for human immunodeficiency virus(HIV-1 performed; specify results ALL: Chronic palifermin, Kepivance started or is there a plan to use it? velafermin started or is there a plan to use it? AML or acute nonlymphocytic leukemia (ANLL? CML: Part 1 of 2.At the time of transplantation, what was the number of the status of the CML? Philadelphia chromosome+, Ph+, t(9;22(q34;q11, or variant OR bcr/abl+? SLE, what was the C4 test result? HBV surface antigen(HBsAg HBV core antibody (Anti HBc HCV antibody (Anti-HCV Anti-HTLV I / II: HIV-1 p24 antigen: NAT for human immunodeficiency virus(HIV-1 performed; specify results NAT for hepatitis C virus performed; specify results antibodies to Human Immunodeficiency Viruses: STS CMV antibody (IgG or total: WNV using nucleic acid amplification test (NAT CFU were assessed, what was the total number of colonies counted? CR ever achieved in response to the HSCT? CFU were assessed, what was the total number of CFU-GM counted? s of death: SGOT? s: s: s: s: s: s: e.g., insulated shipping containers and unit cassette intact when they arrived at your center? e.g.,cord blood unit bag intact upon thawing? histology: ies occurred? ies: CSF total protein value: s: %: kappa: lambda: s diagnosed with neuroblastoma or ganglioneuroma: kappa: CRID assignment: CRID assignment? after resection? m^2 kg in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport AJCC Edition 7 Clinical Tumor T Stage AJCC Edition 7 Clinical Regional Lymph Node N Stage AJCC Edition 7 Clinical Distant Metastasis M Stage AJCC Edition 7 Pathologic Tumor T Stage AJCC Edition 7 Pathologic Regional Lymph Node N Stage AJCC Edition 7 Pathologic Distant Metastasis M Stage AJCC Edition 7 Group Stage in A_ProductReportingRelevantInformation in IndividualCaseSafetyReport s PerformedObservationResult StudyAgent in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport AdverseEvent PerformedProductProblemDiscovery in IndividualCaseSafetyReport in IndividualCaseSafetyReport Product in R_Product in R_Product in R_Product ServiceDeliveryLocation s: ServiceDeliveryLocation StudyLegalSponsor in R_Specimen universal StudyAgent DocumentVersion PerformedMedicalConditionResult Universal in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in R_Product Universal Universal Activity Activity Device Device Organization Organization Person Person Universal in IndividualCaseSafetyReport Universal in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in R_Product Laboratory in R_Product in E_Organization informational in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in IndividualCaseSafetyReport in IndividualCaseSafetyReport in A_ProductReportingRelevantInformation in A_ProductReportingRelevantInformation in E_Place universal in IndividualCaseSafetyReport in R_Product Place in R_Product RegulatoryAuthority in E_Place universal in IndividualCaseSafetyReport in R_Product in E_Place universal in IndividualCaseSafetyReport PerformedActivity Epoch New content StudyActivity PlannedActivity PlannedActivity PlannedActivity DefinedObservationResult PlannedActivity PlannedCriterionGroup DefinedObservationResult PlannedActivity PlannedCriterionGroup PlannedCriterionGroup PlannedCriterionGroup DefinedObservationResult PlannedActivity PlannedCriterionGroup PlannedActivity PlannedActivity PlannedActivity DefinedObservationResult PlannedActivity PlannedCriterionGroup StudyProtocolVersion HealthcareFacility Organization in R_Product in R_Product Product Processor Organization in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in A_ProductReportingRelevantInformation Chemical Abstract Service number committee for Advanced therapies Classification issued Genetically Modified Organism MP in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product MAb? in R_Product in R_Product in R_Product in R_Product choice box.determinerCode in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product in R_Product Product Product Product Product in R_Product in R_Product Need to define the type of investigator Study Principal Investigator will be defined as being responsible for the study as a whole (every protocol should have one Study Principal Investigator) Site Principal Investigator will be person responsible for trial at a site Other potential values for code list of roles: • Coordinating Investigator (person coordinates multi-center site with satellite locations) • Site Representative Investigator • Investigator of Record • Chief Investigator (defined as we define Study PI; new element from Clinical Trials European Directive, EMEA) Modeling session should harmonize these values to develop a comprehensive list of values. In addition, the group discussed Credentialing information - while this is useful for regulatory purposes (1572), it may not be necessary for registries (see Notes for 6/14/05) View Description: The Protocol Representation sub-domain is intended for those involved in the planning and design of a research protocol. The majority of business requirements have come from those involved in clinical trial protocols. It focuses on the characteristics of a study and the definition and association of activities within the protocols, including "arms" and "epochs". It also includes the definitions of the roles that participate in those activities. View Description: The Study Versioning View is intended to show the concepts within BRIDG that are related to a change in a study protocol; that is if a study protocol is changes what information needs to be kept about the old version. The majority of business requirements come from the C3PR project. View Description: This View represents the core aspects of a protocol itself, the people, organizations and roles they may play in the context of a study. Note: This view may absorb the Protocol-Driven Research and Study Design views in BRIDG 3.0. View Description: This view is a representation of the CDISC Trial Design Model (TDM), NCI's Cancer Central Clinical Participant Registry (C3PR) Model and elements drawn from the CDISC HL7 Study Design message. Because of the complexity (and importance) of this model (as the basis for defining a computable representation of a study design) the THC has included several instance diagrams on the subject. The different views of the design, the state-based view (used for planning and analysis) and the control-thread view (used for scheduling and execution), are described in the BRIDG Project Documentation and Release Notes for R1.1. View Description: This view shows the core classes that collectively define protocol-driven research, the domain scoped/defined by the BRIDG model, i.e. the data, organization, resources, and processes involving the assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, or device on a human, animal, or other biologic subject or substance plus all associated regulatory artifacts required or derived from said research. Note that the THC has chosen to disambiguate the term "protocol" (and it's various overloaded terms including "trial" and "study" by defining a core class called StudyProtocol whose semantics enable a StudyProtocol to "contain" all of the various documents that collectively define the protocol and all of the activities that define the study. This view also includes the 'context' classes that are associated with the core StudyProtocol class. Finally, the class DocumentRelationship enables the documents collected in the course of a protocol's lifecycle (i.e. from planning to performing and beyond) to be related to each other with relationship types such as "updates," "replaces," "is a part of," "is an amendment to," etc. Protocol Representation Sub-Domain in IndividualCaseSafetyReport Organization Place Person in IndividualCaseSafetyReport PlannedRandomizationBookAllocation StratumGroup Device PerformingLaboratory SGOT? StudyExecution IND/IDE number suffix in R_Product in R_Product New content HealthcareProvider HealthcareProvider Organization Organization in R_Product in R_Product in R_Product in R_Product RegulatoryAuthority RegulatoryAuthority in R_Product in R_Product in R_Product Scientific Advice from CHMP View Description: The Regulatory sub-domain is intended for those involved in the creation and review of submissions to regulatory authorities. The majority of business requirements come from the regulated product submission (RPS) message specification. It focuses on the documentation required for a product submission to the Food and Drug Administration (FDA). Regulatory Sub-Domain in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport Organization Person in IndividualCaseSafetyReport in IndividualCaseSafetyReport ReportVersion ResearchStaff SafetyReportVersion in IndividualCaseSafetyReport PerformedObservationResult Organization n:PersonRole Person in IndividualCaseSafetyReport ResearchOrganization in IndividualCaseSafetyReport ResourceProvider ResourceProvider Organization Organization Person Person Submission in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport AdverseEvent PerformedProductProblemDiscovery in IndividualCaseSafetyReport in IndividualCaseSafetyReport StatisticalAnalysisPlanVersion in R_ServiceDeliveryLocation informational in R_ServiceDeliveryLocation informational Organization Place in R_ServiceDeliveryLocation informational in R_ServiceDeliveryLocation informational in R_Specimen universal in R_Specimen universal Material PerformedSpecimenCollection in R_Specimen universal StatisticalAnalysisPlanDocumentVersion StatisticalAnalysisPlanVersion StatisticalAnalysisPlanVersion StatisticalAnalysisPlanVersion StatisticalAnalysisPlanVersion View Description: The Statistical Analysis Sub-Domain includes concepts describing the planning and performance of the statistical analysis of data collected during clinical trial research and their relationships. This sub-domain will eventually include the semantics for the entire Statistical Analysis lifecycle, but for BRIDG 3.2, only the Statistical Analysis Plan semantics are included. Statistical Analysis Sub-Domain DefinedStratificationCriterionPermissibleResult StratumGroup StudyProtocolVersion s product name(s Activity DefinedActivity StudyProtocolVersion Study StudyProtocolVersion Product Product StudyProtocol StudyProtocolVersion StudyProtocol HealthcareProvider Organization StudyProtocolVersion StudyObjective StudyOutcomeMeasure Study StudyProtocolVersion StudyObjective StudyObjective estimated or actual estimated or actual StudyOverallStatus StudyExecution StudyExecution StudyProtocol StudyProtocolVersion OversightAuthority StudyExecution ResearchStaff ResearchStaff Study StudyProtocolVersion Document StudyProtocol StudyProtocol in IndividualCaseSafetyReport Phase I Phase III Phase II Phase IV ICH s or Problem(s Studied in IndividualCaseSafetyReport StudyProtocol StudyProtocol StudyRecruitmentStatus Study StudyExecution StudyReference StudyProtocolVersion in IndividualCaseSafetyReport Organization Organization Resource Resource Study StudyExecution StudyResourcing StudyProtocolVersion Study StudyExecution HealthcareFacility n:OrganizationFunctionalRole Organization Organization StudySiteOverallStatus at the protocol location OversightCommittee StudySiteProtocolVersionRelationship StudySiteContact StudySite StudySite n:PersonFunctionalRole ResearchStaff ResearchStaff PlannedStudySite StudyProtocolVersion StudyProtocolVersion StudySite StudyResource StudySpecificStatisticalAnalysisPlan StudySubject StudySubject in IndividualCaseSafetyReport in IndividualCaseSafetyReport StudySiteProtocolVersionRelationship StudySubject Review SDTM and CTOM models This may me used by the External Registry group to model the drug intervention. Include other interventions like behavioral, vaccine, device, procedure. View Description: The Study Conduct sub-domain is intended for those involved in the execution of a research study. The majority of business requirements have come from those involved in clinical trials. It focuses on the activities of conducting the study as well as the results from those activities. status should be BRIDG status Study Conduct Sub-Domain in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in IndividualCaseSafetyReport in R_Product in R_Product n:PersonFunctionalRole BiologicEntity Product Specimen Organization SystemOfRecord Subject in IndividualCaseSafetyReport in R_Product Product Product RegulatoryAssessment RegulatoryAssessment StudyIndIde RegulatoryApplication RegulatoryApplication in R_Product RegulatoryApplicationSponsor RegulatoryApplicationSponsor ReviewableUnit Submission Submission Submission Document DocumentVersion HSCT : Part 1 of 4.If there has been more than one hematopoietic stem cell transplantation, what was the type of the most recent previous hematopoietic stem cell transplantation? were the prior HSC source(s? s of active leukemia: s of relapse/progression: s of disease progression / recurrence: s of primary tumors(s: dcterms:Agent A resource that acts or has the power to act. Agent dcterms:AgentClass A group of agents. Agent Class dcterms:BibliographicResource A book, article, or other documentary resource. Bibliographic Resource The set of regions in space defined by their geographic coordinates according to the DCMI Box Encoding Scheme. DCMI Box dcterms:FileFormat A digital resource format. File Format dcterms:Frequency A rate at which something recurs. Frequency The set of codes listed in ISO 3166-1 for the representation of names of countries. ISO 3166 The three-letter alphabetic codes listed in ISO639-2 for the representation of names of languages. ISO 639-2 The set of three-letter codes listed in ISO 639-3 for the representation of names of languages. ISO 639-3 dcterms:Jurisdiction The extent or range of judicial, law enforcement, or other authority. Jurisdiction dcterms:LicenseDocument A legal document giving official permission to do something with a resource. License Document dcterms:LinguisticSystem Written, spoken, sign, and computer languages are linguistic systems. A system of signs, symbols, sounds, gestures, or rules used in communication. Linguistic System dcterms:Location A spatial region or named place. Location dcterms:LocationPeriodOrJurisdiction A location, period of time, or jurisdiction. Location, Period, or Jurisdiction dcterms:MediaType A file format or physical medium. Media Type dcterms:MediaTypeOrExtent A media type or extent. Media Type or Extent dcterms:MethodOfAccrual A method by which resources are added to a collection. Method of Accrual dcterms:MethodOfInstruction A process that is used to engender knowledge, attitudes, and skills. Method of Instruction The set of time intervals defined by their limits according to the DCMI Period Encoding Scheme. DCMI Period dcterms:PeriodOfTime An interval of time that is named or defined by its start and end dates. Period of Time dcterms:PhysicalMedium Examples include paper, canvas, or DVD. A physical material or carrier. Physical Medium dcterms:PhysicalResource A material thing. Physical Resource The set of points in space defined by their geographic coordinates according to the DCMI Point Encoding Scheme. DCMI Point dcterms:Policy A plan or course of action by an authority, intended to influence and determine decisions, actions, and other matters. Policy dcterms:ProvenanceStatement Any changes in ownership and custody of a resource since its creation that are significant for its authenticity, integrity, and interpretation. Provenance Statement The set of tags, constructed according to RFC 1766, for the identification of languages. RFC 1766 RFC 3066 has been obsoleted by RFC 4646. The set of tags constructed according to RFC 3066 for the identification of languages. RFC 3066 RFC 4646 obsoletes RFC 3066. The set of tags constructed according to RFC 4646 for the identification of languages. RFC 4646 RFC 5646 obsoletes RFC 4646. The set of tags constructed according to RFC 5646 for the identification of languages. RFC 5646 dcterms:RightsStatement A statement about the intellectual property rights (IPR) held in or over a resource, a legal document giving official permission to do something with a resource, or a statement about access rights. Rights Statement dcterms:SizeOrDuration Examples include a number of pages, a specification of length, width, and breadth, or a period in hours, minutes, and seconds. A dimension or extent, or a time taken to play or execute. Size or Duration dcterms:Standard A reference point against which other things can be evaluated or compared. Standard The set of identifiers constructed according to the generic syntax for Uniform Resource Identifiers as specified by the Internet Engineering Task Force. URI The set of dates and times constructed according to the W3C Date and Time Formats Specification. W3C-DTF A summary of the resource. Abstract Access Rights may include information regarding access or restrictions based on privacy, security, or other policies. Information about who access the resource or an indication of its security status. Access Rights Recommended practice is to use a value from the Collection Description Accrual Method Vocabulary [[DCMI-ACCRUALMETHOD](https://dublincore.org/groups/collections/accrual-method/)]. The method by which items are added to a collection. Accrual Method Recommended practice is to use a value from the Collection Description Frequency Vocabulary [[DCMI-COLLFREQ](https://dublincore.org/groups/collections/frequency/)]. The frequency with which items are added to a collection. Accrual Periodicity Recommended practice is to use a value from the Collection Description Accrual Policy Vocabulary [[DCMI-ACCRUALPOLICY](https://dublincore.org/groups/collections/accrual-policy/)]. The policy governing the addition of items to a collection. Accrual Policy The distinction between titles and alternative titles is application-specific. An alternative name for the resource. Alternative Title Recommended practice is to use this property with non-literal values from a vocabulary of audience types. A class of agents for whom the resource is intended or useful. Audience Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Date that the resource became or will become available. Date Available Recommended practice is to include sufficient bibliographic detail to identify the resource as unambiguously as possible. A bibliographic reference for the resource. Bibliographic Citation An established standard to which the described resource conforms. Conforms To The guidelines for using names of persons or organizations as creators apply to contributors. An entity responsible for making contributions to the resource. Contributor Spatial topic and spatial applicability may be a named place or a location specified by its geographic coordinates. Temporal topic may be a named period, date, or date range. A jurisdiction may be a named administrative entity or a geographic place to which the resource applies. Recommended practice is to use a controlled vocabulary such as the Getty Thesaurus of Geographic Names [[TGN](https://www.getty.edu/research/tools/vocabulary/tgn/index.html)]. Where appropriate, named places or time periods may be used in preference to numeric identifiers such as sets of coordinates or date ranges. Because coverage is so broadly defined, it is preferable to use the more specific subproperties Temporal Coverage and Spatial Coverage. The spatial or temporal topic of the resource, spatial applicability of the resource, or jurisdiction under which the resource is relevant. Coverage Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Date of creation of the resource. Date Created Recommended practice is to identify the creator with a URI. If this is not possible or feasible, a literal value that identifies the creator may be provided. An entity responsible for making the resource. Creator Date may be used to express temporal information at any level of granularity. Recommended practice is to express the date, date/time, or period of time according to ISO 8601-1 [[ISO 8601-1](https://www.iso.org/iso-8601-date-and-time-format.html)] or a published profile of the ISO standard, such as the W3C Note on Date and Time Formats [[W3CDTF](https://www.w3.org/TR/NOTE-datetime)] or the Extended Date/Time Format Specification [[EDTF](http://www.loc.gov/standards/datetime/)]. If the full date is unknown, month and year (YYYY-MM) or just year (YYYY) may be used. Date ranges may be specified using ISO 8601 period of time specification in which start and end dates are separated by a '/' (slash) character. Either the start or end date may be missing. A point or period of time associated with an event in the lifecycle of the resource. Date Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Examples of resources to which a date of acceptance may be relevant are a thesis (accepted by a university department) or an article (accepted by a journal). Date of acceptance of the resource. Date Accepted Typically a year. Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Date of copyright of the resource. Date Copyrighted Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Examples of resources to which a 'Date Submitted' may be relevant include a thesis (submitted to a university department) or an article (submitted to a journal). Date of submission of the resource. Date Submitted Description may include but is not limited to: an abstract, a table of contents, a graphical representation, or a free-text account of the resource. An account of the resource. Description A class of agents, defined in terms of progression through an educational or training context, for which the described resource is intended. Audience Education Level Recommended practice is to specify the file size in megabytes and duration in ISO 8601 format. The size or duration of the resource. Extent Recommended practice is to use a controlled vocabulary where available. For example, for file formats one could use the list of Internet Media Types [[MIME](https://www.iana.org/assignments/media-types/media-types.xhtml)]. Examples of dimensions include size and duration. The file format, physical medium, or dimensions of the resource. Format This property is intended to be used with non-literal values. This property is an inverse property of Is Format Of. A related resource that is substantially the same as the pre-existing described resource, but in another format. Has Format This property is intended to be used with non-literal values. This property is an inverse property of Is Part Of. A related resource that is included either physically or logically in the described resource. Has Part Changes in version imply substantive changes in content rather than differences in format. This property is intended to be used with non-literal values. This property is an inverse property of Is Version Of. A related resource that is a version, edition, or adaptation of the described resource. Has Version Recommended practice is to identify the resource by means of a string conforming to an identification system. Examples include International Standard Book Number (ISBN), Digital Object Identifier (DOI), and Uniform Resource Name (URN). Persistent identifiers should be provided as HTTP URIs. An unambiguous reference to the resource within a given context. Identifier This property is intended to be used with non-literal values. This property is an inverse property of Has Format. A pre-existing related resource that is substantially the same as the described resource, but in another format. Is Format Of This property is intended to be used with non-literal values. This property is an inverse property of Has Part. A related resource in which the described resource is physically or logically included. Is Part Of This property is intended to be used with non-literal values. This property is an inverse property of References. A related resource that references, cites, or otherwise points to the described resource. Is Referenced By This property is intended to be used with non-literal values. This property is an inverse property of Replaces. A related resource that supplants, displaces, or supersedes the described resource. Is Replaced By This property is intended to be used with non-literal values. This property is an inverse property of Requires. A related resource that requires the described resource to support its function, delivery, or coherence. Is Required By Changes in version imply substantive changes in content rather than differences in format. This property is intended to be used with non-literal values. This property is an inverse property of Has Version. A related resource of which the described resource is a version, edition, or adaptation. Is Version Of Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Date of formal issuance of the resource. Date Issued Recommended practice is to use either a non-literal value representing a language from a controlled vocabulary such as ISO 639-2 or ISO 639-3, or a literal value consisting of an IETF Best Current Practice 47 [[IETF-BCP47](https://tools.ietf.org/html/bcp47)] language tag. A language of the resource. Language Recommended practice is to identify the license document with a URI. If this is not possible or feasible, a literal value that identifies the license may be provided. A legal document giving official permission to do something with the resource. License In an educational context, a mediator might be a parent, teacher, teaching assistant, or care-giver. An entity that mediates access to the resource. Mediator The material or physical carrier of the resource. Medium Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Date on which the resource was changed. Date Modified An entity responsible for making the resource available. Publisher This property is intended to be used with non-literal values. This property is an inverse property of Is Referenced By. A related resource that is referenced, cited, or otherwise pointed to by the described resource. References Recommended practice is to identify the related resource by means of a URI. If this is not possible or feasible, a string conforming to a formal identification system may be provided. A related resource. Relation This property is intended to be used with non-literal values. This property is an inverse property of Is Replaced By. A related resource that is supplanted, displaced, or superseded by the described resource. Replaces This property is intended to be used with non-literal values. This property is an inverse property of Is Required By. A related resource that is required by the described resource to support its function, delivery, or coherence. Requires Typically, rights information includes a statement about various property rights associated with the resource, including intellectual property rights. Recommended practice is to refer to a rights statement with a URI. If this is not possible or feasible, a literal value (name, label, or short text) may be provided. Information about rights held in and over the resource. Rights This property is intended to be used with non-literal values. The described resource may be derived from the related resource in whole or in part. Best practice is to identify the related resource by means of a URI or a string conforming to a formal identification system. A related resource from which the described resource is derived. Source Spatial characteristics of the resource. Spatial Coverage Recommended practice is to refer to the subject with a URI. If this is not possible or feasible, a literal value that identifies the subject may be provided. Both should preferably refer to a subject in a controlled vocabulary. A topic of the resource. Subject A list of subunits of the resource. Table Of Contents Temporal characteristics of the resource. Temporal Coverage A name given to the resource. Title Recommended practice is to use a controlled vocabulary such as the DCMI Type Vocabulary [[DCMI-TYPE](http://dublincore.org/documents/dcmi-type-vocabulary/)]. To describe the file format, physical medium, or dimensions of the resource, use the property Format. The nature or genre of the resource. Type Recommended practice is to describe the date, date/time, or period of time as recommended for the property Date, of which this is a subproperty. Date (often a range) of validity of a resource. Date Valid The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort . The BRIDG model is an instance of a Domain Analysis Model (DAM). The goal of the BRIDG Model is to produce a shared view of the dynamic and static semantics for the domain of protocol-driven research and its associated regulatory artifacts. This domain of interest is further defined as: Protocol-driven research and its associated regulatory artifacts: i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting. 2012-08-31 en-US Biomedical Research Integrated Domain Group (BRIDG) Domain Analysis Model bridg:Activity Unless constrained at any subclass level, all associations from Subject (including StudySubject) and ExperimentalUnit are valid for all activities. true Activity Any action that can, in the context of a study or a post-marketing investigation, be defined, planned, scheduled or performed. Administrative activities such as subject registration or informed consent Clinical activities such as surgical procedure administration of a drug laboratory test This is similar in idea to HL7 RIM's Act class Unless constrained at any subclass level, all associations from Subject (including StudySubject) and ExperimentalUnit are valid for all activities. be participated in by Declaration false comment Additional description of the activity. Guidance on how to perform the observation. (for DefinedObservation.comment) false identifier A unique symbol that establishes identity of an activity. 12345 is the identifier for a substance administration none false involvedExperimentalUnit be participated in by none false involvedSubject be participated in by false reasonCode A coded value specifying the motivation, cause, or rationale of an activity. drug reaction infectious disease reporting requirement on patient request routine requirement The key difference in how this attribute is used across the Activity subclasses is temporal and the attribute has essentially the same meaning wherever it is used. The most likely uses of reasonCode are with PlannedActivities, where it identifies why an activity should be done as part of the study plan, and with PerformedActivities, where it identifies why an activity was done. While it's possible for a DefinedActivity to have a reason, BRIDG has no use cases for the use of this attribute in a DefinedActivity, though some may come to harmonization in the future. Nor is it likely, based on existing use cases, to be used much, if at all, for ScheduledActivities. bridg:AdministrativeMemberCRA false AdministrativeMemberCRA A clinical research associate (CRA) at a site who has the primary responsibility for communications and data related to a specific organizational network in which that site participates. Jane Doe is the Primary CRA for ECOG at Mayo Clinic; she receives all of the ECOG communications at Mayo and distributes them appropriately. bridg:AdministrativeMemberPI false AdministrativeMemberPI The principal investigator (PI) at a site who is responsible for all activities related to a specific organizational network's research at that site. "Dr. Smith" is the ECOG site PI at Mayo Clinic. "Dr. Jones" is the site PI for the GOG network participation at Mayo Clinic. They are responsible for the overall management of the entire network's (ECOG GOG) studies in which the Mayo Clinic participates. bridg:AdverseEvent false AdverseEvent Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. back pain death headache heart attack pulmonary embolism The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every AdverseEvent be described by a SafetyReportVersion. false categoryCode A coded value specifying a classification of the adverse event. bleeding hypoglycemia Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. true endRelativeToReferenceCode A coded value specifying the end of the adverse event with respect to the sponsor-defined reference period. after before during during/after Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected. Derived from AdverseEvent.occurrenceDateRange.IVL<TS.DATETIME>.high.TS.DATETIME.uncertainRange.IVL<TS.DATETIME>.high = PerformedStudySubjectMilestone.studyReferenceDateRange then "BEFORE" AND AdverseEvent.occurenceDateRange.IVL<TS.DATETIME>.low.TS.DATETIME.uncertainRange.IVL<TS.DATETIME>.low = PerformedStudySubjectMilestone.studyReferenceDateRange then "AFTER" false expectedIndicator Specifies whether the specificity (nature), frequency, or severity of an adverse event is consistent with the applicable study documentation (e.g., investigator's brochure, protocol document, or consent document) or product labeling (package insert). true gradeCode A coded value specifying the level of injury suffered by the subject or study subject for whom the event is reported. The gradeCode could be 3 if the CTCAE coding system is being used. Derived from PerformedClinicalInterpretation.value(ANY=>CD).code WHERE PerformedObservationResult > PerformedObservation > DefinedObservation.nameCode = "grade assessment" false highlightedIndicator Specifies whether the adverse event or reaction term is a major concern or reason for reporting the adverse event. false hospitalizationRequiredIndicator Specifies whether the subject or study subject requires hospitalization or prolongation of existing hospitalization as a result of the adverse event. false locationDescription The textual representation of the physical location of the subject or study subject when the adverse event began. false occurrenceDateRange duration onset date resolution date The date and time span in which the adverse event began and ended. These may be partial dates or durations (duration is the width property of the IVL<TS> data type). false occurrencePatternCode A coded value specifying the time recurrence by which an adverse event occurs. continuous intermittent single event false postReportUpdateDate The date (and time) on which the adverse event was updated after it had been submitted. true severityCode A coded value specifying the intensity of the event. Moderate could be used to describe acne. Derived from the maximum severity observed during the course of the AdverseEvent: PerformedClinicalInterpretation.value(ANY=>CD).code WHERE PerformedClinicalInterpretation > PerformedObservation > DefinedObservation.nameCode = "assess severity" AND PerformedObservation > AssessedResultRelationship > AdverseEvent. false subcategoryCode A coded value specifying a subdivision within a larger category of an adverse event. neurologic Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. false summary A description of the adverse event and the treatment of the event. false treatmentEmergentIndicator Specifies whether the adverse event is something that first arose or become more severe during the studied treatment. This may be derivable if a complete study subject history exists and it can be known with certainty whether (and with what severity) a condition may have pre-existed. However, this information is not always available and therefore the attribute has not been marked as derived. false unexpectedReasonCode A coded value specifying why an adverse event (experience or reaction) is considered unanticipated. frequency or specificity from what has been previously documented severity bridg:AdverseEventOutcomeAssessment Associations from Subject (including StudySubject) are valid for BiologicEntity and BiologicEntityGroup, not for Product, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. false AdverseEventOutcomeAssessment The completed action of evaluating the final state of a subject or study subject who experienced an adverse event, which takes place after the adverse event occurs. Associations from Subject (including StudySubject) are valid for BiologicEntity and BiologicEntityGroup, not for Product, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. be participated in by Qualifier none false triggeringAdverseEvent is triggered by bridg:AdverseEventOutcomeResult false AdverseEventOutcomeResult The result of evaluating the final state of a person who experienced an adverse event. Fatal Not Recovered/Not Resolved Recovered/Resolved Recovered/Resolved with Sequelae Recovering/Resolving Unknown bridg:AdverseEventSeriousness false AdverseEventSeriousness Specifies the degree or extent of the consequence suffered by the subject or study subject. required hospitalization resulted in death was life threatening false code A coded value specifying the degree or extent of the consequence suffered by the subject or study subject. Results in Death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; In the medical judgment of the treating physician and/or investigator it may jeopardize the participant or require intervention to prevent one of these outcomes; Other required hospitalization resulted in death specify; Meets criteria per protocol but does not meet other criterion (NCI CRF Standard) was life threatening false date The date (and time) on which the seriousness code was assigned to the adverse event. none false describedAdverseEvent describes bridg:AmendmentChangeSummaryVersion false AmendmentChangeSummaryVersion Amendment A document, memo or brief that enumerates the differences between two versions of a study protocol document. The term "Amendment" needs to be disambiguated since it sometimes refers to the amended version of the protocol (StudyProtocolDocumentVersion) and other times refers to the summary of changes (AmendmentChangeSummaryVersion) that are applied to a protocol to create a new version of the protocol. bridg:Animal false Animal A non-human living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral. cat dog microorganism mouse false breedCode A coded value specifying a group of animals presumably related by descent from common ancestors and are visibly similar in most characteristics. Angora Himalayan cat Holstein Labrador Retriever false description A textual or media-based representation of the animal. audio track digital photo paragraph description false reproductiveOrgansPresentIndicator Specifies whether the anatomical parts of the body involved in reproduction are present. If the animal has been spayed or neutered reproductiveOrgansPresentIndicator = "false". false speciesCode A coded value specifying one of the basic units of biological classification and taxonomic rank that specifies a group of organisms that share similar characteristics and can interbreed with one another to produce fertile offspring. Canis lupus Rattus rattus Assuming this is a two-part name, a "binomial name". The first part of a binomial name is the generic name, the genus of the species. The second part is also called the specific name. false strain A group of presumed common ancestry with clear-cut physiological but usually not morphological distinctions. DXL (poultry strain) Minnesota5 (swine strain) RB51 (vaccine strain of brucella abortus) The specific genotypic or phenotypic variant of an animal. bridg:Arm An Arm name must be unique within the context of the study that contains it. At least one of the following attributes must be mandatory for Arm: name, typeCode. armType is only valid for InterventionalStudyProtocolVersion. false Arm Group [CTRR Observational Studies] A path through the study which describes what activities the study subject or experimental unit will be involved in as they pass through the study. A study could have 2 arms named IV-Oral and Oral-IV. The name IV-Oral reflects a path that passes through IV treatment then Oral treatment. An Arm is typically equivalent to a treatment group in a parallel design study. Generally, each subject is assigned to an arm, and the design of the study is reflected in the number and composition of the individual arms. This intended path through which the subject progresses in a study is composed of time point events (study cell) for each epoch of the study. Each time point event, in turn, has a pattern of child time points through which the subject would pass. This planned path thus describes how subjects assigned to the arm will be treated. An Arm name must be unique within the context of the study that contains it. name Unique At least one of the following attributes must be mandatory for Arm: name, typeCode. Mandatory Attribute Qualifier armType is only valid for InterventionalStudyProtocolVersion. armType Qualifier none false containedPlannedActivity contains false description The textual representation of the arm. This is a description of the pathway followed by all subjects, study subjects, or experimental units in a particular treatment regimen. Experimental units receive Placebo Study subjects receive Drug X Study subjects receive drug A IV in the first phase drug B Oral in the second phase This description should point out what is different between the Arms, if there is more than one Arm. false name A non-unique textual identifier for the arm. Treatment A false randomizationWeight The relative proportion of study subjects to be randomized to the arm. If 1/3 of study subjects are to be randomized to Arm A and 2/3 to Arm B could be expressed as 1 and 2 or as 1/3 and 2/3. respectively then the values of randomizationWeight for Arms A and B none false subdividedStudyProtocolVersion is a division of false targetAccrualNumberRange An integer falling within minimum and maximum bounds that specifies how many study subjects are to be accrued for the arm. This may represent the minimum number of study subjects needed to support data analysis and/or the maximum number of study subjects that may be accrued to this arm. false typeCode A coded value specifying the kind of arm. Active Comparator Experimental No intervention Other Placebo Comparator Sham Comparator bridg:AssessedActivityRelationship false AssessedActivityRelationship Specifies the link between an assessment (performed observation) and the performed activity that the assessment is based on. The act of determining if graft failure occurred involves assessing a stem cell transplant. bridg:AssessedResultRelationship false AssessedResultRelationship Specifies the link between an assessment (performed observation) and the results of other performed observations that the assessment is based on. The acts of determining whether an adverse event occurred determining a diagnosis or determining a cause of death may each be based on evaluating several test results (PerformedObservation). none false assessedPerformedObservationResult has as subject none false assessingPerformedObservation is the subject of false typeCode A coded value specifying the kind of assessed result relationship. cause component sequel to bridg:Assessor Assessor might be a function performed by one and only one of the following: Subject, AssociatedBiologicEntity, HealthcareProvider, ResearchStaff, OversightCommittee, Laboratory, Device. false Assessor The person, organization, or device making an observation. adjudication committee family member healthcare provider heart rate monitor pace maker. radiologist vendor (may provide a uniform assessment for all sites participating in a study) Assessor might be a function performed by one and only one of the following: Subject, AssociatedBiologicEntity, HealthcareProvider, ResearchStaff, OversightCommittee, Laboratory, Device. be a function performed by Exclusive Or none false performingAssociatedBiologicEntity be a function performed by none false performingDevice be a function performed by none false performingHealthcareProvider be a function performed by none false performingOversightCommittee be a function performed by none false performingResearchStaff be a function performed by none false performingSubject be a function performed by bridg:AssociatedBiologicEntity A performer BiologicEntity and a scoper BiologicEntity may be associated to one another through AssociatedBiologicEntity more than once but the typeCode must be distinct (no duplicate performer/scoper/type triples). false AssociatedBiologicEntity An individual biologic entity connected/linked to another biologic entity. family member nursing home attendant roommate A performer BiologicEntity and a scoper BiologicEntity may be associated to one another through AssociatedBiologicEntity more than once but the typeCode must be distinct (no duplicate performer/scoper/type triples). Performer Scoper Type Unique none false performingBiologicEntity is a function performed by none false scopingBiologicEntity is scoped by false typeCode A coded value specifying the kind of associated biologic entity. family member guardian nursing home attendant roommate bridg:Biologic false Biologic A substance made from a living organism or thing it produces. allergenic product analogous product antitoxin blood blood component or derivative therapeutic serum toxin vaccine virus false handlingCode A coded value specifying a special handling requirement for the biologic. keep at room temperature store upright false riskCode A coded value specifying the type of hazard or threat associated with the biologic. explosive flammable false stabilityDuration The period of time during which the biologic is considered usable after it is activated (opened). bridg:BiologicEntity A BiologicEntity cannot be a PlannedStudySubject of a study if it is part of a BiologicEntityGroup that is a PlannedStudySubject of the same Study. A BiologicEntity cannot be a StudySubject of a study if it is part of a BiologicEntityGroup that is a StudySubject of the same Study. name, birthDate, deathDate are valid only when actualIndicator = "true". true BiologicEntity organism Any individual living (or previously living) being. animal human being A BiologicEntity cannot be a PlannedStudySubject of a study if it is part of a BiologicEntityGroup that is a PlannedStudySubject of the same Study. functions as PlannedStudySubject Qualifier A BiologicEntity cannot be a StudySubject of a study if it is part of a BiologicEntityGroup that is a StudySubject of the same Study. functions as StudySubject Qualifier name, birthDate, deathDate are valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false actualIndicator Specifies whether the biologic entity is a particular instance (actual) vs. universal kind. To indicate a particular BiologicEntity actualIndicator = "false". actualIndicator = 'true". To indicate a kind of BiologicEntity false administrativeGenderCode A coded value specifying the physical or societal properties by which male is distinguished from female. For humans, identification of sex is usually based upon self-report and may come from a form, questionnaire, interview, etc. false birthCountryCode A coded value specifying the name of the country in which the biologic entity is born. false birthDate The date (and time) on which the biologic entity is born. false birthOrder Indicates the sequence of a biologic entity's birth in the family group. false deathDate The date (and time) on which the biologic entity died. This BRIDG SCC reserves the option of re-modeling this in future since death date itself might be better modeled as an observation result and this attribute might better be represented as an uncertaintyCode on that observation result. false deathDateEstimatedIndicator Specifies whether the death date is approximate. This BRIDG SCC reserves the option of re-modeling this in future since death date itself might be better modeled as an observation result and this attribute might better be represented as an uncertaintyCode on that observation result. false deathIndicator Specifies whether the biologic entity is dead. This BRIDG SCC reserves the option of re-modeling this in future since death date itself might be better modeled as an observation result and this attribute might better be represented as an uncertaintyCode on that observation result. false name A non-unique textual identifier for the biologic entity. assumed name of "Mark Twain" customary name of "Sam Clemens" official registry name of "Samuel Clemens" The EN.use attribute of the EN data type is used to distinguish the various types of names, such as official registry, customary, assumed. bridg:BiologicEntityGroup containedBiologicEntityGroup must have the same value for actualIndicator as their containingBiologicEntityGroup. name is valid only when actualIndicator = "true". false BiologicEntityGroup A collection of biologic entities. flock of ducks herd of cows litter of mice containedBiologicEntityGroup must have the same value for actualIndicator as their containingBiologicEntityGroup. contain actualIndicator Qualifier name is valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false actualIndicator Specifies whether the biologic entity group is a particular instance (actual) vs. universal kind. To indicate a particular BiologicEntityGroup actualIndicator = "false". actualIndicator = "true". To indicate a kind of BiologicEntityGroup shared false groupedBiologicEntity groups false name A non-unique textual identifier for the biologic entity group. Farmer Brown's Cows Litter1 X12 false quantity The number of members in a biologic entity group. false typeCode A coded value specifying the kind of biologic entity group. herd litter bridg:BiologicEntityIdentifier Only BiologicEntity with actualIndicator = "true" is valid. Only Organization with actualIndicator = "true" is valid. false BiologicEntityIdentifier The unique identification of a biologic entity in a specified context. This class is a resolution of the requirement for noting the type of an identifier which is not handled by the purely technical HL7 II data type. Only BiologicEntity with actualIndicator = "true" is valid. identifies actualIndicator Qualifier Only Organization with actualIndicator = "true" is valid. is assigned by actualIndicator Qualifier none false assigningOrganization be assigned by false effectiveDateRange The date (and time) span for when the biologic entity identifier is active. none false identifiedBiologicEntity identifies false identifier A unique symbol that establishes identity of the biologic entity. medical record number This is different from the SubjectIdentifier.identifier. false missingIdentifierReasonCode A coded value specifying why the identifier was not provided. forgot to ask subject refused This value should only be populated if BiologicEntityIdentifier.identifier is null. false typeCode A coded value specifying the kind of biologic entity identifier. hospital record number medical record number bridg:BiologicEntityPart quantity shall only be permitted when the BiologicEntity.actualIndicator="false" and the BiologicEntityPart does not have an association to ExperimentalUnit. false BiologicEntityPart A limb, organ, or other portion of a biologic entity. a dog's right front paw a patch of skin on a person's left forearm the left kidney of a person quantity shall only be permitted when the BiologicEntity.actualIndicator="false" and the BiologicEntityPart does not have an association to ExperimentalUnit. quantity actualIndicator Qualifier false anatomicSiteCode A coded value specifying the anatomic location or system of the biologic entity part. eye kidney skin Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false anatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) where the anatomic site is in a biologic entity part. both left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. none false containingBiologicEntity is part of false quantityRange An integer falling within minimum and maximum bounds that specifies how many parts that need to be present. 2 Skin patches Default is 1. Normally used during study design to indicate number of parts that will be used in a study. For example 100 study subjects with 3-5 skin patches. bridg:CausalAssessment Associations from Subject (including StudySubject) are valid for BiologicEntity and BiologicEntityGroup, not for Product, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. false CausalAssessment The judgment of relatedness between an adverse event and an activity or observation result. The activity of administering a concomitant medication is assessed to have caused the AE. The activity of administering the study drug is assessed to have caused the AE. The observation result of "diabetes" is assessed to have caused the AE. Associations from Subject (including StudySubject) are valid for BiologicEntity and BiologicEntityGroup, not for Product, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. be participated in by Qualifier none false triggeringAdverseEvent is triggered by bridg:CollectingLaboratory false CollectingLaboratory The laboratory that collects the specimen from an experimental unit. none false performingLaboratory is a function performed by bridg:CompanionStudyRelationship false CompanionStudyRelationship Specifies the link between a parent study and a companion study. The relationship exists between the version of the parent study and the non-versioned concept of the companion study because the relationship may be added in a new version of the parent study and references the overall notion of the companion study, not a particular version of the companion study. none false accompaniedStudyProtocolVersion is a companion of none false accompanyingStudyProtocol has as a companion false registrationRequiredIndicator Specifies whether registration to the companion study is mandatory when registering to the parent study. bridg:ConcomitantAgent false ConcomitantAgent Substance used by the study subject either prior to or during the study that are not specified by the protocol. Blood pressure medication prescribed either before or during a chemotherapy therapeutic trial. alcohol tobacco DEPRECATED in BRIDG 3.1 because it was determined that the distinction between StudyAgent and ConcomitantAgent is no longer needed for performed activities (it was never made for defined activities). To be consistent all associations from (defined and performed) activities will now be directly to Product. StudyAgent will only be associated to StudyProtocolVersion, not to any activities. ConcomitantAgent is no longer needed. BRIDG does not yet have a business requirement to include illicit use of drugs or abuse of drugs as concomitant agents. none false performingProduct is a function performed by none false usingPerformedProcedure is used during bridg:CooperativeGroup false CooperativeGroup A group of researchers, cancer centers, and community doctors who provide infrastructure for studies of new cancer treatment, prevention, early detection, quality of life, and rehabilitation. Eastern Cooperative Oncology Group (ECOG) Southwest Oncology Group (SWOG). bridg:CooperativeGroupMember false CooperativeGroupMember An organization comprised of a group of treating sites. A group of cancer centers with outreach clinics forming a loose confederation for research purposes. bridg:Cosmetic false Cosmetic An article intended to be rubbed, poured, sprinkled, or sprayed on or introduced into or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. false stabilityDuration The period of time during which the cosmetic is considered usable after it is activated (opened). bridg:DataMonitoringCommitteeCharterVersion false DataMonitoringCommitteeCharterVersion A key document that, together with the study protocol and Statistical Analysis Plan (SAP), prospectively defines the study's Data Monitoring Committee (DMC) infrastructure and, in particular, the DMC's responsibilities; stipulates who sees blinded results and who sees unblinded results; and establishes a method for communication between the DMC and the sponsor. false description A textual explanation of the contents of the data monitoring committee charter. "Data will be presented via blinded summaries and listings in PDF format "Meetings will be held monthly If the charter is about meeting schedules beginning 6 weeks after the first subject's first visit." then the description could be with additional availability of unblinded patient profiles in electronic format. The following is a description of the data to be included in the summaries and listings¦ none false influencedStatisticalAnalysisPlanVersion influence bridg:DefinedActivity A DefinedActivity may have a value for one and only one of the following: repeatDuration or repeatQuantity. A DefinedActivity may have a value for one and only one of the following: repeatFrequencyCode or repeatFrequencyRatio. Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = “false” is valid. false DefinedActivity An activity that frequently occurs in studies (e.g. more than one time in more than one arm) and therefore is called out as a reusable template in a global library of activities outside the context of any particular study, and may be used in the composition of a defined subject activity group. A defined activity is a "kind of" activity rather than an "instance of" an activity. Standard blood chemistries are frequently included in studies - also activities that are study-specific and recur more than one time in more than one arm may be defined such as a substance administration activity involving X amount of drug Y. A defined activity is represented here as a subtype of Activity, but could also be thought of as an activity at a particular stage in the business process in which the activities occur, i.e., in the "defined" stage rather than the "planned" stage, the "scheduled" stage or the "performed" stage. A DefinedActivity may have a value for one and only one of the following: repeatDuration or repeatQuantity. Repeat Duration or Quantity Exclusive Or A DefinedActivity may have a value for one and only one of the following: repeatFrequencyCode or repeatFrequencyRatio. Repeat Frequency Exclusive Or Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = “false” is valid. be participated in by actualIndicator Qualifier false categoryCode A coded value specifying a classification of activities. "Milestone" (informed consent "urinalysis" For lab procedures In AdministrativeActivity In Procedure In the case where categoryCode = "anti-cancer treatment" and the nameCode may = "external beam radiotherapy". categoryCode may = "abdominal surgery". categoryCode may = "hematology" enrollment epoch completion) or "chemistry". randomization) or "Other" (unblinding) activities. registry the categoryCode may = "Disposition" (off study the subcategoryCode may = "radiotherapy" Theoretically speaking, the categoryCode should be derivable from the subcategoryCode, however if there may only be a category and not a subcategory, then both attributes must be present in the model. When value sets are defined for this attribute, we may need to move it to the DefinedActivity subclasses so that the different value domains can be bound to the correct subclass. false description The textual representation of the activity. This may contain more detail than the description present in the text part of a coded concept. false nameCode A coded value specifying the non-unique textual identifier for the activity. CPT4 or SNOMED term for a surgical procedure. Coded value for a single analytic procedure in a lab test. The code and text of an individual question on the eligibility checklist of a protocol. The textual description of the activity is captured in the complex data type CD. true repeatDuration The period of time over which the activity is repeated. Derived from repeatQuantity and repeatFrequencyCode or repeatFrequencyRatio (constraint allows only one). In any given implementation, if quantity is not provided, duration may be provided instead, however the BRIDG team determined that quantity is considered more fundamental for a domain analysis model. false repeatFrequencyCode A coded value specifying the number of occurrences of an activity within a given time period. BID = Two times per day Q12H = Every twelve hours at unspecified times (does not necessarily imply that these are 12 hours apart) false repeatFrequencyRatio A ratio representing the number of occurrences of an activity within a given time period. 2 times per day Once per 12 hours false repeatQuantityRange An integer falling within minimum and maximum bounds that specifies how many times the activity occurs. If the frequency is more than once a day, this is still interpreted per time, e.g. BID for 5 days = 10 repeats. false statusCode A coded value specifying the phase in the lifecycle of the activity as part of a global library. Draft New Released Retired Archived Please refer to the Defined Activity Status state transition diagram for further details. false statusDate The date (and time) on which the status is assigned to the activity. false subcategoryCode A coded value specifying a subdivision within a larger category of activities. "Behavioral" (e.g. "Biological/Vaccine" "Device" (including sham) "Genetic" (including gene transfer "Procedure/Surgery" "Radiation" Dietary Supplement. If categoryCode = "Intervention" In the case where categoryCode = "anti-cancer treatment" Lifestyle Counseling) Psychotherapy alternative therapy and nameCode may = "external beam radiotherapy". chemotherapy hormonal therapy radiotherapy stem cell and recombinant DNA) subcategoryCode may = "Drug" (including placebo) subcategoryCode may = "radiotherapy" Theoretically speaking, the categoryCode should be derivable from the subcategoryCode, however if there may only be a category and not a subcategory, then both attributes must be present in the model. bridg:DefinedAdministrativeActivity false DefinedAdministrativeActivity An activity defined at a global library level that is not directly related to hypothesis evaluation or testing, but is typically essential to the efficient and/or effective coordination and execution of a study. assignment to a treatment arm break treatment blind complete study visits end of on-study period enroll exit trial obtain informed consent premature withdrawal protocol violation randomize registration to a study start of on-study period verify eligibility criteria bridg:DefinedAdverseEvent false DefinedAdverseEvent A reusable, template description of any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. back pain death headache heart attack pulmonary embolism false categoryCode A coded value specifying a classification of the adverse event. bleeding hypoglycemia Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. false severityCode A coded value specifying the intensity of the event. Moderate could be used to describe acne. false subcategoryCode A coded value specifying a subdivision within a larger category of an adverse event. neurologic Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. bridg:DefinedCompositionRelationship false DefinedCompositionRelationship A relationship between a composite activity and a component activity that comprises it, i.e. parent and child activities, where all these activities are part of a global library of activities. A battery of tests may be composed of multiple routine labs that are always ordered together as a group. A glucose tolerance test which is comprised of administering glucose and taking multiple timed blood samples which are then tested for glucose. This class helps represent an AND relationship between siblings with the same parent activity. none false componentDefinedActivity is the parent of none false compositeDefinedActivity is the component of false joinCode A coded value specifying whether, and how, a specific activity in a set of parallel activities should come together before subsequent activities can begin. Wait for this activity to complete before the subsequent activity; Terminate this activity as soon as all parallel "wait" activities are completed (and if this activity hasn't started yet but don't wait for it to complete before beginning subsequent activities. don't start it at all); Continue this activity after all "wait" activities complete false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false sequenceNumber An integer specifying the relative sequential or temporal ordering of this relationship among other similar relationships having the same source. In a course of treatment (a composite activity) that is composed of a chemotherapy activity and a radiotherapy activity, the sequence number indicates which component activity precedes the other. bridg:DefinedContingentOnRelationship A DefinedContingentOnRelationship must be associated to one and only one of the following: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. completionRequiredBeforeStartingIndicator may only be used if the target of this relationship is an activity, not if the target is an observation result or a criterion group. false DefinedContingentOnRelationship A relationship between an activity and some criteria to determine if the activity should occur where all activities are part of the global library of activities. Only perform a certain lab test if drug X was administered. (target = another activity) Only perform a substance administration of drug X if the blood pressure was over some threshold number. (target = observation result from another activity that is an observation) Only perform a substance administration of drug Y if the blood pressure was over some threshold number and either the result of a certain lab test was positive or the subject's temperature was elevated i.e. "(A and (B or C))". The criteria to evaluation the relationship could be one of the following: - the outcome of another activity where the source activity does not occur unless the target activity outcome has occurred - another activity where the source activity does not occur unless the target activity has occurred - a group of other criteria that may be composed of a mix of other activities, observation results and/or other groups. To evaluate whether the contingency was satisfied, the simple existence of a PerformedActivity (or subclass) related to the DefinedActivity (or subclass) is not enough by itself. The PerformedActivity.statusCode and PerformedActivity.negationIndicator must also be checked to ensure that the activity was actually performed. PerformedActivity.statusCode must be "Completed" and PerformedActivity.negationIndicator must not be "true". A DefinedContingentOnRelationship must be associated to one and only one of the following: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. be contingent upon Exclusive Or completionRequiredBeforeStartingIndicator may only be used if the target of this relationship is an activity, not if the target is an observation result or a criterion group. completionRequiredIndicator Qualifier false checkpointCode The checkpointCode specifies when the precondition is to be checked; it is analogous to the various conditional statements and loop constructs in programming languages "while-do" vs. "do-while" or "repeat-until" vs. "loop-exit." false completionRequiredBeforeStartingIndicator Specifies whether the target activity must have completed prior to starting the source activity. This attribute may only be used if the target is an activity, not if the target is an observation result or a criterion group. none false contingentDefinedActivity is a condition for false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. For the more complex examples of doing activity A 5 minutes after the start of B or 5 minutes after the end of B Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. use pauseQuantity in combination with completionRequiredBeforeStartingIndicator where the pauseQuantity in both cases would be 5 minutes and "after the start of" would be completionRequiredBeforeStartingIndicator = "false" and "after the end of" = "true". The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. none false prerequisiteDefinedActivity be contingent upon none false prerequisiteDefinedCriterionGroup be contingent upon none false prerequisiteDefinedObservationResult be contingent upon false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. bridg:DefinedCriterionGroup false DefinedCriterionGroup A collection of conditions joined together via composition (ANDed) and/or optionality (ORed) to form a logical expression upon which the execution of an activity is based or upon which the cessation of a repeated activity is based, where components of the group may include other activities, observation results and/or other criterion groups, and where both the criterion group and it's components are defined as part of the global library. (A and (B or C)) B and C might be 2 different observation results and the two sets of parentheses are 2 criterion groups one inside (a component of) the other. where A might be an activity A criterion group represents the parentheses around a set of criteria in a logical expression. bridg:DefinedCriterionGroupCompositionRelationship A DefinedCriterionGroupCompositionRelationship must be associated to one and only one of the following targets: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. false DefinedCriterionGroupCompositionRelationship A relationship between a criterion group and an activity, observation result or other criterion group that is a component of the group, i.e. a relationship between a logical set of parenthesis and one of the items inside the parentheses, where the criterion group and its components are both part of a global library of activities. A battery of tests may be composed of multiple routine labs that are always ordered together as a group. A glucose tolerance test which is comprised of administering glucose and taking multiple timed blood samples which are then tested for glucose. This class helps represent an AND relationship between siblings in the same criterion group. A DefinedCriterionGroupCompositionRelationship must be associated to one and only one of the following targets: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. is the component of Exclusive Or none false componentDefinedActivity be the parent of none false componentDefinedCriterionGroup be the parent of none false componentDefinedObservationResult be the parent of none false compositeDefinedCriterionGroup is the component of false joinCode A coded value specifying whether, and how, a specific activity in a set of parallel activities should come together before subsequent activities can begin. Wait for this activity to complete before the subsequent activity; Terminate this activity as soon as all parallel "wait" activities are completed (and if this activity hasn't started yet but don't wait for it to complete before beginning subsequent activities. don't start it at all); Continue this activity after all "wait" activities complete false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false sequenceNumber An integer specifying the relative sequential or temporal ordering of this relationship among other similar relationships having the same source. In a criterion group that is composed of a substance administration activity and a lab test activity the sequence number indicates which activity precedes the other. bridg:DefinedCriterionGroupOptionRelationship A DefinedCriterionGroupOptionRelationship must be associated to one and only one of the following targets: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. false DefinedCriterionGroupOptionRelationship A relationship between a criterion group and an option that can satisfy it, either an activity, observation result or other criterion group, i.e. a relationship between a logical set of parenthesis and one of the options inside the parentheses, where the criterion group and its option are both part of a global library of activities. A pain management criterion group may be comprised of three options and a third for substance administration of ibuprofen. The pain management criterion would be satisfied/accomplished with any one of these activities and would be associated to each of the three via a different DefinedCriterionGroupOptionRelationship. another for substance administration of aspirin one for substance administration of Tylenol This class helps represent an OR relationship between siblings in the same criterion group. A DefinedCriterionGroupOptionRelationship must be associated to one and only one of the following targets: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. be the choice that has as option Exclusive Or none false choiceDefinedCriterionGroup is an option that can satisfy none false optionDefinedActivity be a choice that has as option none false optionDefinedCriterionGroup be a choice that has as option none false optionDefinedObservationResult be a choice that has as option false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. bridg:DefinedEligibilityCriterion Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. false DefinedEligibilityCriterion An activity defined at a global library level that identifies one of a set of conditions that a subject must meet in order to participate in a study, or that a study subject must meet into order to participate in a certain part of the study. Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier false requiredResponse The reply necessary to include/exclude a potential subject on a study. bridg:DefinedEligibilityCriterionAnswer false DefinedEligibilityCriterionAnswer A reusable, "template" description of an allowable response to an eligibility criterion question. false requiredIndicator Specifies whether this reply is necessary to include/exclude a potential subject on a study. This attribute is only intended to be used when the required answer is defined in the context of the question, regardless of in which study it is used. bridg:DefinedExclusionCriterion false DefinedExclusionCriterion An activity defined at a global library level that identifies a characteristic or requirement intended to be applied to a potential study subject to determine whether they may not participate in a study. Must be over the age of 18. bridg:DefinedExperimentalUnitAllocation Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid. The Repeat attributes should not be used for a DefinedExperimentalUnitAllocation. false DefinedExperimentalUnitAllocation An administrative activity defined at a global library level that is the assignment of an experimental unit to a portion of the study, such as an arm or a portion of an arm (when secondary allocations may occur). "Escalating dose cohort studies" enroll subjects in successive arms allocation depends on which arms have been fully enrolled and which are currently open for enrollment. Note that this example assumes that the experimental unit is the subject (rather than a part of a subject or a group of subjects). direct assignment based on eligibility criteria etc. i.e. one arm is completely filled before any subjects are enrolled in the next arm. In such a study randomization Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid. be participated in by Qualifier The Repeat attributes should not be used for a DefinedExperimentalUnitAllocation. Repeat Not Applicable false methodCode A coded value specifying the technique that is used for allocating experimental units. adaptive allocation based on past response. blocked stratified bridg:DefinedExpressionVariableRelationship false DefinedExpressionVariableRelationship A relationship between a DefinedSubstanceAdministration and a DefinedObservation that identifies a factor used in a relative dose expression to calculate an absolute dose. Relationship of a calculated dose on a substance administration and a body surface area observation. Relationship of a calculated dose on a substance administration and a weight observation. Formulas are used for direct mathematical calculations. Conditional assertions make use of the DefinedContingentOnRelationship class. false localVariableName A label that represents the result value of an observation and serves as an input parameter used in a dose expression. The local variable name is used in the DefinedSubstanceAdministration.dose.EXPR<PQ> and will ultimately be substituted with the result of the observation to which the DefinedExpressionVariableRelationship points. none false referencedDefinedObservation is a reference to none false usingDefinedSubstanceAdministration is used in bridg:DefinedImaging Associations from Subject (including StudySubjects) and ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart, and Specimen, not for Product, ProductGroup, Organization or HealthcareFacility. false DefinedImaging An activity defined at the global library level whose intention is to obtain pictures of the interior or exterior of the body usually for diagnostic reasons. MRI X-ray Associations from Subject (including StudySubjects) and ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart, and Specimen, not for Product, ProductGroup, Organization or HealthcareFacility. be participated in by Qualifier false contrastAgentEnhancementIndicator Specifies whether the image is enhanced by the use of a contrast agent. false enhancementDescription The textual representation for how an image is enhanced either physically or electronically. false enhancementRate The numeric value to indicate an increase in voxel signal over time for an MRI, expressed as signal intensity units per second. bridg:DefinedInclusionCriterion false DefinedInclusionCriterion An activity defined at a global library level that identifies a characteristic or requirement intended to be applied to a potential study subject to determine whether they may participate in a study. pregnancy bridg:DefinedMaterialProcessStep false DefinedMaterialProcessStep product manipulation An activity defined at a global library level that is an action of processing a material. adding additives or growth factors aliquot dividing embedding freezing spinning thawing Material process may be performed on any kind of material, such as a specimen, nanomaterial, or biologic. The result of the process may a similar or different kind of material, for instance a specimen may be the result of a specimen processing step (e.g., aliquot or division of a specimen), or alternatively a blood product has anticoagulants added to it to preserve the product. Other processsing steps, such as adding growth factor to induce cell growth, may be performed on the blood product. bridg:DefinedMaterialStorage Associations from Subject (including StudySubject) and ExperimentalUnit are valid for Specimen and Product, not for BiologicEntity, BIologicEntityPart, BiologicEntityGroup, ProductGroup, HealthcareFacility or Organization. false DefinedMaterialStorage An administrative activity defined at a global library level that is an action of safekeeping harvested material in a repository or depository. cryopreservation dehydration refrigeration There is a difference between the act of changing the state of material, which is represented by DefinedMaterialProcessStep, and the act of maintaining state of the material by storing it, which is represented by DefinedMaterialStorage. Associations from Subject (including StudySubject) and ExperimentalUnit are valid for Specimen and Product, not for BiologicEntity, BIologicEntityPart, BiologicEntityGroup, ProductGroup, HealthcareFacility or Organization. be participated in by Qualifier bridg:DefinedMedicalConditionResult false DefinedMedicalConditionResult Clinical Events Medical History A reusable template description of a sign, symptom, disease, or other medical occurrence. back pain broken bone death depression flu headache heart attack menstrual period pregnancy pulmonary embolism bridg:DefinedNotification Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. Only Organization or Person (via NotificationReceiver) with actualIndicator = "false" is valid. false DefinedNotification An administrative activity defined at the global library level that represents the communication of a message to a recipient. An alert sent to a study PI that the study has reached 75% of target subject accrual. Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only Organization or Person (via NotificationReceiver) with actualIndicator = "false" is valid. be received by actualIndicator Qualifier false deliveryMechanismCode A coded value specifying how the notification message is to be delivered. email false message The text that is to be included in the notification. The message text may contain substitution tags that when used in the context of a particular study are replaced with study name or study site, etc. false messageTitle The topic of the notification. bridg:DefinedObservation false DefinedObservation An activity defined at a global library level whose intention is to obtain a result by observing, monitoring, measuring or otherwise qualitatively or quantitatively gathering data or information about one or more aspects of a subject's, study subject's or experimental unit's physiologic or psychologic state. blood chemistry panel blood pressure measurement body mass index calculation false approachAnatomicSiteCode A coded value specifying the anatomic location or access point for an observation. Anus for a colonoscopy observation Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the acces point for the measurement or observation and the target site is what is ultimately being evaluated. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false bodyPositionCode A coded value specifying the 3-dimensional spatial orientation of a subject during a particular observation. standing supine trendelenburg false focalDateRange The time period in which the observation result is held to be true, expressed either as a simple date range or as an evaluable expression that references a study-defined date or milestone. "Have you smoked in the last 2 months" "Have you traveled to Europe between 1990 and 1999?" 1990 to December 31 1999". For a survey question For the question the focalDateRange would be "January 1 the focalDateRange would be an expression referencing a variable that represents the PerformedObservation.actualDateRange (a value yet to be defined) and a formula for the date range between when the question is asked (PerformedObservation.actualDateRange.low) and 2 months prior (PerformedObservation.actualDateRange.low - 2 months). As an attribute with data type IVL<EXPR<TS.DATETIME>>, focalDateRange can be used to express a simple date range such as "January 1, 1990 to December 31, 1999" or a relative time expression that includes a variable that represents another date in the model that is a study-defined anchor point. The other date may or may not be known at the time the DefinedObservation is created, but will be known by the time the PerformedObservation is created. true focalDuration A quantity of time in which the observation result is held to be true. "Have you smoked in the last 2 months?" 2 months is the focalDuration for the question The focalDuration can be derived from the expression captured in the focalDateRange.IVL<EXPR<TS.DATETIME>>. none false focusingDefinedObservationResult have as focal context false methodCode A coded value specifying the technique that is used for the observation. Arterial puncture Estrogen Receptor Assay Global introspection Progesterone Receptor Assay algorithm bayesian (for Adverse Event causality) p53 Assay (for clinical result assay) sphygmomanometry (for blood pressure measurement) false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of the observation. leg lung The target site of the observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (e.g. skin) while the target site of the observation result is specific (e.g. skin on chest). Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for an observation. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. bridg:DefinedObservationResult false DefinedObservationResult A reusable, "template" description of possible findings of an observation. A blood pressure measurement may result in a diastolic number and a systolic number. The DefinedObservationResult class can be used to represent defined ranges for contingencies by constraining the result attribute from ANY to IVL<PQ>, for instance, or any other range value. Such DefinedObservationResults may be used as criteria for conditional activities or repeated activities. false comment Additional description of the observation result. false confidentialityCode A coded value specifying the degree of privacy applicable for the observation result. false derivationExpression A character string containing a formal language expression that specifies how the observation result's attributes are, should be, or have been derived from input parameters associated with activity. none false producingDefinedObservation is a result of false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of an observation result. Arm for skin rash. The target site of the observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (e.g. skin) while the target site of the observation result is specific (e.g. skin on chest). Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for a procedure. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. false targetCodingSystem The coding system to use for recording results for the associated activity or evaluation. false typeCode A coded value specifying the kind of observation result. For blood pressure the results might be 120 for systolic and 80 for diastolic where systolic and diastolic are the typeCode distinguishing the two numbers. false value Data or information that is determined by an act of observation. The adverse event term code. The result of a lab test physical finding self-reported symptom. The DefinedObservationResult class can be used to represent defined ranges for contingencies by constraining the result attribute from ANY to IVL<PQ>, for instance, or any other range value. Such DefinedObservationResults may be used as criteria for conditional activities or repeated activities. false valueNegationIndicator Specifies whether, when the observation event occurred, the finding communicated by the value attribute was NOT found. This attribute should only be used when the terminology used for DefinedObservationResult.value is not itself capable of expressing negated findings (e.g., ICD9). bridg:DefinedOptionRelationship false DefinedOptionRelationship A relationship between a composite activity and an option that can satisfy it, i.e. choice and option activities, where all these activities are part of a global library of activities. A pain management activity may be comprised of three options and a third for substance administration of ibuprofen. The pain management activity would be satisfied/accomplished with any one of these activities and would be associated to each of the three via a different DefinedOptionRelationship. another for substance administration of aspirin one for substance administration of Tylenol This class helps represent an OR relationship between siblings with the same parent activity. none false choiceDefinedActivity is an option that can satisfy none false optionDefinedActivity is a choice that has as option false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. bridg:DefinedProcedure Only Product with actualIndicator = “false” is valid. false DefinedProcedure An activity defined at a global library level that is an action whose immediate and primary intention is the alteration of the physical condition of the subject, study subject or experimental unit. Conservative procedures such as reduction of a luxated joint Procedures may involve the disruption of some body surface (e.g. an incision in a surgical procedure). acupuncture balneotherapy including physiotherapy such as chiropractic treatment massage shiatsu. Only Product with actualIndicator = “false” is valid. use actualIndicator Qualifier false approachAnatomicSiteCode A coded value specifying the anatomic location or access point for a procedure. Arm for an injection Trans-abdominal for a nephrectomy Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false approachAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is an access point for a procedure. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. false methodCode A coded value specifying the technique that is used for the procedure. "Abdominal/ ascites effusion" "Biopsy" "Bronchial alveolar lavage (BAL)". "laproscopic". "veni puncture" For a cholecystectomy For a specimen collection the methodCode could = "finger stick" the methodCode could = "open" false nameCodeModifiedText A character string that is a revision of the original text of the procedure to enable the coding of the text. If the original text is "message" so that the text can be successfully coded. the nameCodeModifiedText could be set to "massage" In the context of BRIDG, text modification occurs a single time for a given instance of originalText. false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of a procedure. Kidney for a nephrectomy Multiple contiguous sites within the same organ system may be referenced. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for a procedure. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. none false usedProduct use bridg:DefinedRepeatActivityUntilRule A DefinedRepeatActivityUntilRule must be associated to one and only one of the following: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. false DefinedRepeatActivityUntilRule A relationship between a defined repeating activity and the criteria that may trigger the repeating activity to stop, where all items are part of a global library. Continue repeating kidney dialysis until kidney transplant surgery. Continue performing a certain lab test weekly until the three-month checkup occurs. (target = another activity) Continue substance administration of drug X until the blood pressure is over some minimum threshold number. (target = observation result from another activity that is an observation) Continue substance administration of drug Y until the blood pressure is over some minimum threshold number and either the result of a certain lab test is positive or the subject's temperature is elevated i.e. "(A and (B or C))". The criteria to stop the repeating activity by be one of the following: - another defined activity where the repeating activity stops if this other activity occurs - a defined observation result where the repeating activity stops if this observation result occurs - a defined criteria group where the repeating activity stops if this group logically evaluates to true based on its components A DefinedRepeatActivityUntilRule must be associated to one and only one of the following: DefinedActivity, DefinedObservationResult, DefinedCriterionGroup. be repeated until Exclusive Or false cessationPauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time after the observed result occurs and before the cessation of repeating the activity. Stop 20 days after the observed event occurs. false checkpointCode The checkpointCode specifies when the precondition is to be checked; it is analogous to the various conditional statements and loop constructs in programming languages "while-do" vs. "do-while" or "repeat-until" vs. "loop-exit." false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. none false repeatedDefinedActivity triggers the cessation of none false triggeringDefinedActivity be repeated until none false triggeringDefinedCriterionGroup be repeated until none false triggeringDefinedObservationResult be repeated until bridg:DefinedSpecimenCollection Only Material (via Specimen) with actualIndicator = “false” is valid. false DefinedSpecimenCollection An activity defined at a global library level that is an action of gathering samples that may be used for subsequent analysis. blood draw Only Material (via Specimen) with actualIndicator = “false” is valid. results in actualIndicator Qualifier none false producedSpecimen results in bridg:DefinedStratificationCriterion A DefinedStratificationCriterion must be associated with 2 or more DefinedStratificationCriterionPermissibleResults. Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. false DefinedStratificationCriterion An activity defined at a global library level that identifies pre-treatment factors by which study subjects are segregated to assure balance of these factors during analysis or before randomization to a study arm or some smaller segment of a study. The decisive factor used to help segregate the study subject into a stratum group for analysis or randomization purposes. A DefinedStratificationCriterion must be associated with 2 or more DefinedStratificationCriterionPermissibleResults. Permissible Result Qualifier Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier bridg:DefinedStratificationCriterionPermissibleResult For associations between DefinedStratificationCriterion and DefinedStratificationCriterionPermissibleResult (via DefinedObservation and DefinedObservationResult), the cardinality should be 2..* on the DefinedStratificationCriterionPermissibleResult. false DefinedStratificationCriterionPermissibleResult A reusable, "template" description of an allowable response to a stratification criterion. The stratification criterion for gender can have permissible answers of male and female For associations between DefinedStratificationCriterion and DefinedStratificationCriterionPermissibleResult (via DefinedObservation and DefinedObservationResult), the cardinality should be 2..* on the DefinedStratificationCriterionPermissibleResult. Association Cardinality Qualifier bridg:DefinedStudyAdministrativeActivity Associations from Subject (including StudySubject) and ExperimentalUnit are not valid. false DefinedStudyAdministrativeActivity An administrative activity defined at a global library level that is independent of a study subject but is necessary for the conduct of the study. FDA audit IRB Approval site enrollment Associations from Subject (including StudySubject) and ExperimentalUnit are not valid. be participated in by Not Applicable bridg:DefinedStudyAgentTransfer Associations from Product are valid only for Products that are associated to StudyAgent with the same StudyProtocolVersion as the StudyProtocolVersion associated to the DefinedStudyAgentTransfer. Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. Only Product with actualIndicator = "false" is valid. false DefinedStudyAgentTransfer An administrative activity defined at a global library level that is an action in which an authorized party at a designated study site dispenses or receives a study agent to/from a study subject, though as a defined activity, no actual study subject is identified. Dispensing a bottle of pills The term "study agent" only pertains within the context of a given study. To make this explicit in BRIDG it was determined that the StudyAgent class would only be used to connect Product to StudyProtocolVersion. All activity-related classes would be associated directly to Product to avoid the issues of activities that may cross study boundaries. To determine if a given activity uses a study agent one need only compare the product used in the activity with the list of products associated to StudyAgent for a given StudyProtocolVersion. It should be noted that this determination could be different for different studies and could evolve over the course of a given study. Associations from Product are valid only for Products that are associated to StudyAgent with the same StudyProtocolVersion as the StudyProtocolVersion associated to the DefinedStudyAgentTransfer. is a transfer of Qualifier Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only Product with actualIndicator = "false" is valid. is a transfer of actualIndicator Qualifier bridg:DefinedStudySubjectMilestone Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. false DefinedStudySubjectMilestone An administrative activity defined at a global library level that represents a common administrative landmark for a study subject in the course of a study. assignment to a treatment arm break treatment blind complete study visits end of on-study period enroll exit trial obtain informed consent premature withdrawal protocol violation randomize registration to a study start of on-study period verify eligibility criteria Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier none false usedDocumentVersion use bridg:DefinedSubjectActivityGroup Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. false DefinedSubjectActivityGroup course cycle period study segment treatment strategy A collection of activities from a global library that would be performed on a common study subject. A treatment strategy that consists of drug administrations with rules for modifying doses Clinic visit during which a physical exam Recording multiple observation results in a diary Telephone contact during which temperature a blood test and a substance administration occur blood pressure and adverse events are reported Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier bridg:DefinedSubstanceAdministration Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. If a dose expression uses parameters, each parameter must be defined as a DefinedExpressionVariableRelationship.localVariableName. productDose, periodProductDoseTotal must only be used when the DefinedSubstanceAdministration is associated to a single Product. Otherwise, it would be ambiguous to which Product the amounts indicated in these attributes apply. false DefinedSubstanceAdministration An activity defined at a global library level that is an action of applying, introducing or otherwise giving medications or other substances to a subject or experimental unit. Administration of methotrexate as part of chemotherapy. Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. be participated in by Qualifier If a dose expression uses parameters, each parameter must be defined as a DefinedExpressionVariableRelationship.localVariableName. Dose Expression Qualifier productDose, periodProductDoseTotal must only be used when the DefinedSubstanceAdministration is associated to a single Product. Otherwise, it would be ambiguous to which Product the amounts indicated in these attributes apply. Dose Qualifier false doseFrequencyCode A coded value specifying how often doses are administered. BID QID TID false dosePeriodCode A coded value specifying the period during which the dose total is administered. course daily false doseRegimen Text description of the intended schedule for administering a substance. 2 weeks off 2 weeks on This represents the dosing calendar in a text format. This is a non-computational description that may need to be expanded as additional use cases arise. false flowRate A ratio specifying the speed with which the substance is introduced into the subject. 1 g/d 100 mL/h 40 mmol/h false periodProductDoseTotal Total of all doses of this agent in a given period of time. The given period of time is defined in dosePeriodCode. This is needed because the dose may not always be derivable, e.g., if it is a string, and because it is often used as a cross-check on dose to ensure mistakes are not made in dosing subjects. false productDose The quantity of a substance or medication to be administered. 20 mg of drug per kg of subject weight 5 mg DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or relative terms (e.g., mg or mg/kg). ScheduledSubstanceAdministration.activeIngredientDose and PerformedSubstanceAdministration.productDose must contain a dose expressed in absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was expressed in relative terms (e.g., mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the DefinedExpressionVariableRelationship. false routeOfAdministrationCode A coded value specifying the physiological path or method of introducing the substance. intracardial intradermal intravenous nasal oral bridg:Device effectiveDateRange, codeModifiedText, lotNumberText, expirationDate, manufactureDate, returnedToReprocessorDate are valid only when actualIndicator = "true". false Device An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes. EKG machine insulin pump mass spectrometer microscope pH meter pacemaker polymerase chain reaction (PCR) machine tongue depressor x-ray machine effectiveDateRange, codeModifiedText, lotNumberText, expirationDate, manufactureDate, returnedToReprocessorDate are valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier true age A measure (or best estimate) of the length of time during which a device existed, measured from manufacture date (and time) to a given date (and time) of use. Derived from the difference between the manufacture date and the date of the activity in which it is used. This is not really a characteristic of the device since the device could be used in multiple activities. false availableForEvaluationIndicator Specifies whether or not the device is accessible for assessment by the manufacturer. false ceMarkIndicator Specifies whether this device bears a CE (Conformite Europeenne) mark. CE is a mark for device products placed on the market in the European Economic Area (EEA). By placing the CE marking on a product, the manufacturer affirms that the product conforms with the requirements of the applicable European Community directives. false handlingCode A coded value specifying special handling requirements for the device. keep at room temperature store upright false manufactureDate The date (and time) on which the device is made. false overTheCounterProductIndicator Specifies whether a device is available over-the-counter. false reprocessedDeviceCode A coded value specifying whether a device is reconditioned. initial use of device reuse unknown false returnedToReprocessorDate The date (and time) on which the device was returned to the manufacturer or reprocessor. false riskCode A coded value specifying the type of hazard or threat associated with the device. explosive flammable false singleUseDeviceIndicator Specifies whether a device is intended to be used only one time. bridg:Distributor false Distributor An organization who takes part in the distribution chain for a product, as it is moved from its producer to the ultimate consumer. bridg:Document false Document An organized representation of information in publishable, human-readable form (that persists over time). Adverse Event Report Autopsy Report Expedited Adverse Event Report Institutional Review Board (IRB) Report Lab Summary Report Study Protocol X-Ray Report A document groups the various document versions and has the following characteristics: 1) Stewardship, 2) Potential for authentication, 3) Wholeness, 4) Human readability, 5) Persistence, 6) Global vs local context (the person that signs it is the author of all sections unless otherwise noted). Regulatory processes require the submission of documents from the Applicant to the Regulatory Authority. These documents are varied in focus and are often defined by the field of study or by the regulatory application requirements of the region or Regulatory Authority (e.g., Integrated Summary of Safety, Pharmacokinetics Written Summary). false typeCode A coded value specifying the kind of document. Data Clarification Form (DCF) amendment background material guide regulatory record In RPS, this is the code that specifies how the file is to be used within the submission process (e.g. Protocol, Summary Introduction). Also known as context of use. RegulatoryRecord - A document that meets a recording requirement of a regulatory authority and must be retained in accordance with that agency's records retention requirements bridg:DocumentAuthor A DocumentAuthor is a function performed by one and only one of the following: ResearchStaff, Subject, AssociatedBiologicEntity, HealthcareProvider. Each DocumentVersion can have more than one DocumentAuthor but each of them must be a different ResearchStaff, Subject, AssociatedBiologicEntity, or HealthcareProvider (no duplicate Person/ResearchOrganization pairs). The DocumentAuthor must be a function performed by a Subject who is a Person and not an Animal or Product or Specimen. When the DocumentAuthor is an author for a StudyProtocolDocumentVersion, the DocumentAuthor must be a function performed by a HealthcareProvider or ResearchStaff only. false DocumentAuthor The individual who is responsible for the content of a document. A healthcare provider could be the author of a study protocol document A DocumentAuthor is a function performed by one and only one of the following: ResearchStaff, Subject, AssociatedBiologicEntity, HealthcareProvider. be a function performed by Exclusive Or Each DocumentVersion can have more than one DocumentAuthor but each of them must be a different ResearchStaff, Subject, AssociatedBiologicEntity, or HealthcareProvider (no duplicate Person/ResearchOrganization pairs). Performer Document Pair Unique The DocumentAuthor must be a function performed by a Subject who is a Person and not an Animal or Product or Specimen. be a function performed by Qualifier When the DocumentAuthor is an author for a StudyProtocolDocumentVersion, the DocumentAuthor must be a function performed by a HealthcareProvider or ResearchStaff only. Study Author performed by Qualifier none false authoredDocumentVersion authors none false performingAssociatedBiologicEntity be a function performed by none false performingHealthcareProvider be a function performed by none false performingResearchStaff be a function performed by none false performingSubject be a function performed by bridg:DocumentIdentifier A DocumentIdentifier is assigned by one and only one of the following: Organization, StudyRegistry, SystemOfRecord. Only Organization with actualIndicator = "true" is valid. false NOTE: Until further clarification, the BRIDG SCC believes the IND/IDE regulatory application serial number is the number assigned by the applicant/sponsor to a document that is either a supplement or an amendment to the original submission unit and is represented using DocumentIdentifier.identifer. DocumentIdentifier The unique identification of a document in a specified context. In context of a study protocol document document identifiers are the various unique identifiers assigned to a study by different organizations. This class is a resolution of the requirement for noting the type of an identifier which is not handled by the purely technical HL7 II data type. A DocumentIdentifier is assigned by one and only one of the following: Organization, StudyRegistry, SystemOfRecord. be assigned by Exclusive Or Only Organization with actualIndicator = "true" is valid. be assigned by actualIndicator Qualifier none false assigningOrganization be assigned by none false assigningStudyRegistry be assigned by none false assigningSystemOfRecord be assigned by none false identifiedDocument identifies false identifier A unique symbol that establishes identity of the document. A study protocol identifier is assigned by the National Cancer Institute (NCI). A particular document can have one or more ID. false primaryIndicator Specifies whether this is the main or principal document identifier. primaryIndicator may only apply for a given typeCode. none false resulted inPerformedStudyAdministrativeActivity be assigned during false typeCode A coded value specifying the kind of document identifier. CDISC protocol identifying number cooperative group protocol number national number registry identifier sponsor protocol number bridg:DocumentVersion DocumentVersion.languageCode must equal DocumentVersion.text(ED).languageCode if both are non-null. false DocumentVersion A representation of a particular edition or snapshot of a document as it exists at a particular point in time. Version 3 of a case report form (CRF) for a physical exam version 2 of an informed consent form. DocumentVersion.languageCode must equal DocumentVersion.text(ED).languageCode if both are non-null. language Qualifier false bibliographicDesignation A text block containing publishing and authoring information that allows receivers of this document version to refer appropriately to this document version. 18-Jan-2008 Good Health Hospital IRB Minutes false confidentialityCode A coded value specifying the degree of sensitivity associated with the document. Normal Restricted Very Restricted false date The date (and time) on which the document is versioned. false keywordCode A coded value specifying the words or phrases that best describe the document and/or its context. Keywords help users find documents of interest. biocompatibility drug product drug substance indication species false keywordText A character string of a word or phrase that describes the document and/or its context. Keywords help users find documents of interest. biocompatibility drug product drug substance indication species false languageCode A coded value specifying the language that the document is written in. English German This attribute is used to indicate the language in which all (or most) of the discrete data elements that make up the document are expressed. This is distinct from the DocumentVersion.text(ED).languageCode property which expresses the language in which the document is rendered. This attribute is most important in circumstances where the document is not rendered. false numberText A character string that identifies a given collection of content of a document at a point in time. In RPS this could be implemented as follows: The version number would be an integer starting at '1' and incrementing by 1. The first instance or original report should always be valued as '1'. The version number value must be incremented by one when a report is replaced but can also be incremented more often to meet local requirements. Different versions of the same document belong to the same document group. Over time, there may be multiple changes to a document, and the version allows an individual to capture relationships between changes in the instances of a document over time. There can be a new version every time the content changes. false officialTitle The formal title of the document. If there is only one title, use this attribute. false revisionReasonCode A coded value specifying why the document is revised. false text A textual or media-based representation that is the full or comprehensive narrative or content of the document. true uniformResourceLocator A complete or local reference to a website, ftp, file path or other location from which the document contents can be retrieved. Derived from DocumentVersion.text.ED.reference. Local references should only be used when communicating between systems capable of resolving the local reference. In a Regulatory Product Submission (RPS) message, this identifies the file (with a Uniform Resource Identifier (URI)), which is part of the documentation. A URI is a compact string of characters used to identify or name a resource. The main purpose of this identification is to enable interaction with representations of the resource over a network, typically the World Wide Web, using specific protocols. URIs are defined in schemes defining a specific syntax and associated protocols. none false versionedDocument is a version of bridg:DocumentVersionRelationship false NOTE: BRIDG SCC acknowledges that there are two ways to represent the relationship between a study protocol and a document that is cited by the study protocol: 1) use the StudyProtocolVersion to StudyReference association; 2) use the StudyProtocolVersion > StudyProtocolDocumentVersion > DocumentVersionRelationship associations. The first is more direct and uses domain terminology, while the second is more consistent with other document-to-document associations. The SCC hopes to clarify this ambiguity in a future release when a project dealing with publications or a related area comes to harmonization. DocumentVersionRelationship Specifies the meaning (or semantics) of the relationship between one document version and another. The DocumentVersions on either side of the DocumentVersionRelationship do not necessarily have to be related to the same Document, or even have the same Document.typeCode. false priorityNumber A number specifying the relative rank for one document before other similar documents having the same type of association to the same source document. A report initiated by the primary physician may be ranked higher than reports initiated by specialty consultants or support staff. Relationships with lower priorityNumber values are considered before and above those with higher values. There may be multiple investigations (and therefore reports) into the same event, each initiated by a different party. The priorityNumber may be used to rank these investigations. The ordering may be a total ordering, in which all priority numbers are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. none false sourceDocumentVersion has as source none false targetDocumentVersion has as target false typeCode A coded value specifying the kind of document relationship. Each value implies specific constraints to what kinds of objects can be related and in which way. attribution (cause and effect) decomposition (component) modifies) post-condition pre-condition sequel (replaces This is HL7 structured vocabulary and is part of a controlled vocabulary set. bridg:DocumentVersionWorkflowStatus false DocumentVersionWorkflowStatus The workflow status associated with a document version from submission thru abstraction. Please refer to the Processing Status state transition diagram for further details. false code A coded value specifying the phase in the lifecycle of the document version workflow. Abstracted Abstraction Verified Abstraction not verified Accepted Created On-hold Rejected available [examples for HL7 StudyDesign Structured Document] Please refer to the Processing Status state transition diagram for further details. A state transition diagram needs to be developed for the HL7 StudyDesign Structured Document examples. false comment Additional description of the workflow status. to capture the reasons of statuses or other notes false date The date (and time) on which the status is assigned to the document version workflow. none false describedDocumentVersion describes bridg:DonorRegistry false DonorRegistry An organization that administers the registration of donors of materials for transplantation. 'Be The Match' registry maintained by the National Marrow Donor Program (NMDP) The registry should contain basic information about each donor sufficient to identify duplicate entries and match donors to potential recipients. There may be names for the registry, e.g., "Be The Match", however, we do not have a requirement for adding this at this time. bridg:Drug false Drug An article other than food intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body. aspirin false actionModeCode A coded value specifying the mode of action through which this substance produces a pharmacological effect. blocking/antagonizing action depressing action direct beneficial chemical reaction direct harmful chemical reaction. exchanging/replacing substances stabilizing action stimulating action false handlingCode A coded value specifying special handling requirements for the drug. keep at room temperature store upright false riskCode A coded value specifying the type of hazard or threat associated with the drug. explosive flammable false stabilityDuration The period of time during which the drug is considered usable after it is activated (opened). bridg:Epoch An Epoch name must be unique within the context of the study that contains it. At least one of the following attributes must be mandatory for Epoch: name, typeCode, sequenceNumber. false Epoch One of a set of ordered partitions of a subject's, study subject's or experimental unit's participation in a study. An Epoch represents a state within a study such that subjects in separate arms within that state are comparable. Each epoch serves a purpose in the study as a whole, typically exposing the subject to a treatment or preparing them for a treatment, or gathering post-treatment data. Activities and activity results control the subject's movement from one epoch to another. A Follow-up Epoch during which post-treatment assessments are conducted. A Screening Epoch in which subjects' eligibility is determined and baseline measurements are made. A Treatment Epoch during which treatments are given and effects of treatment are assessed. A study designed to assess the effects of treatments might have 3 epochs. A subject moves from one epoch to another and can only be in one epoch at a time. The subject can only move to an epoch with a greater sequenceNumber. Activities in the same epoch but a different arm need not be similar in time and pattern. Subjects in different arms will not necessarily pass through the same epochs. An Epoch name must be unique within the context of the study that contains it. name Unique At least one of the following attributes must be mandatory for Epoch: name, typeCode, sequenceNumber. Mandatory Attribute Qualifier false description The textual representation of the epoch. "A 2-week period during which eligibility is determined and baseline measurements are taken". "The first treatment epoch is a one-week period during which a single dose of one of the three investigational treatments is administered". false name A non-unique textual identifier for the epoch. first treatment epoch first wash-out epoch second treatment epoch second wash-out epoch When multiple Epochs have the same purpose (e.g., treatment), then the titles will probably include order numbers to distinguish them. false sequenceNumber An integer specifying the relative sequential or temporal ordering of this epoch among other similar epochs in a study. In a Study that has Screening Treatment and Follow-Up epochs the sequence number indicates which Epoch precedes the other. none false subdividedStudyProtocolVersion is a division of true targetAccrualNumberRange An integer falling within minimum and maximum bounds that specifies how many study subjects to be accrued for the epoch. Derived from the summary of all arm accruals in that Epoch. This will be the same as the study level target accrual unless this study has parallel Epochs, in which case the summary will only count the accruals for arms in this Epoch. false typeCode A coded value specifying the kind of epoch. follow-up screening treatment bridg:EvaluatedActivityRelationship false EvaluatedActivityRelationship Specifies the link between an adverse event causal assessment and the activity evaluated as a possible cause. Administration of cold medicine may be evaluated as a cause of an adverse event. none false evaluatedPerformedActivity evaluates none false evaluatingCausalAssessment is evaluated by false probabilityCode A coded value specifying the likelihood of the identified cause of an adverse event. definite (for adverse events in respect to CTEP and FAET) not related (for adverse events in respect to SDTM & E2B) possible possibly related probable related unlikely unlikely related unrelated false probabilityPercent A number representing the likelihood of the identified cause of an adverse event. 60% likelihood that an adverse event was caused by an activity that was performed on the subject or study subject. false uncertaintyCode A coded value specifying whether and to what degree this evaluation or observation has been asserted to be in doubt in any way. bridg:EvaluatedResultRelationship false EvaluatedResultRelationship Specifies the link between an adverse event causal assessment and the observation result evaluated as a possible cause. A diagnosis of diabetes may be evaluated as a cause of an adverse event. none false evaluatedPerformedObservationResult evaluates none false evaluatingCausalAssessment is evaluated by false probabilityCode A coded value specifying the likelihood of the identified cause of an adverse event. definite (for adverse events in respect to CTEP and FAET) not related (for adverse events in respect to SDTM & E2B) possible possibly related probable related unlikely unlikely related unrelated false probabilityPercent A number representing the likelihood of the identified cause of an adverse event. 60% likelihood that an adverse event was caused by the evaluated result of diabetes. false uncertaintyCode A coded value specifying whether and to what degree this evaluation or observation has been asserted to be in doubt in any way. bridg:ExpandedAccessStudyProtocolVersion false ExpandedAccessStudyProtocolVersion An action plan of a pre-clinical or clinical study describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. This type of study is used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. (Parallel track means there is a separate group of subjects that go through the same protocol activities but that didn't get on the main study due to different reasons such as eligibility criteria, location, etc. and their outcome data is collected and analyzed, just not analyzed with the other data, rather in parallel.) false interventionDescription A character string that provides the key details of the intervention. IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.) Interventions involving drugs may include dosage form dosage frequency and duration. (50 mg/m2 bridg:ExperimentalUnit An ExperimentalUnit may be a function performed by one and only one of the following: BiologicEntityPart, BiologicEntity, BiologicEntityGroup, Product, ProductGroup, Specimen. false ExperimentalUnit A physical entity which is the primary unit of interest in a specific research objective. A human may have 10 patches of skin each considered an experimental unit. A product may have 10 bearings in it If all pigs in a pen receive the same intervention in their feed and the primary observations and analyses of interest are associated with the entire pen (e.g. total feed consumed each considered an experimental unit. Alternatively the whole human or product may be an experimental unit. then the pen of pigs rather than the individual animal is the experimental unit. [example from the CDISC/HL7 Study Participation message] total weight of all pigs combined) Depending on the research objectives, a single study may have multiple levels of experimental units, such as whole people and patches of skin. In an interventional study, the experimental unit is assigned to an intervention. The experimental unit is also the unit of primary statistical analysis. Commonly the individual study subject (animal, person or product) is the experimental unit. Different experimental units must be capable of receiving different experimental interventions. An ExperimentalUnit may be a function performed by one and only one of the following: BiologicEntityPart, BiologicEntity, BiologicEntityGroup, Product, ProductGroup, Specimen. be a function performed by Exclusive Or false identifier A unique symbol that establishes identity of the experimental unit. patient number 7 on a study none false performedArm have performed Indicates that an ExperimentalUnit was, at the end of their participation in a study, assigned to a particular arm based on their actual path through the study. This is derivable if the set of performed activities the ExperimentalUnit participated in are available. none false performingBiologicEntity be a function performed by none false performingBiologicEntityGroup be a function performed by none false performingBiologicEntityPart be a function performed by none false performingProduct be a function performed by none false performingSpecimen be a function performed by false statusCode A coded value specifying the phase in the lifecycle of the experimental unit. active cancelled nullified pending suspended terminated Please refer to the HL7 Role Status state transition diagram for further details. false statusDate The date (and time) on which the status is assigned to the experimental unit. false subgroupCode A coded value specifying the identification of uniform groups of experimental units for separate analysis or treatment. Clinical Data Update System (CDUS) Reporting (for the National Cancer Institute (NCI) bridg:FoodProduct false FoodProduct A substance consumed by a human or animal for nutritional purposes. broccoli donuts pet treats false stabilityDuration The period of time during which the food product is considered usable after it is activated (opened). bridg:Funding false Funding Fiscal support for research from industry, government, or non-commercial, non-governmental organizations. Funding from pharmaceutical device or biotechnology companies the US NIH or the Gates Foundation. bridg:GeneralStatisticalConsideration false GeneralStatisticalConsideration Information needed for conducting multiple analyses. Centers within a region with fewer than 3 subjects will be grouped into a pooled center for the region. none false containingStatisticalAnalysisPlanVersion is part of Identifies the considerations that inform the detailed design of the analysis plan. false text Textual or media-based representation of the general statistical consideration. Centers within a region with fewer than 3 subjects will be grouped into a pooled center for the region. Visits will be assigned to assessment windows defined by +/- 7 days from the target visit date as defined in the Time and Events Schedule. If multiple visits fall within an assessment window the earliest visit date will be used. the visit closest to the target date will be used. In the case of a tie false typeCode A coded value specifying the kind of general statistical consideration. analysis set assessment window center pooling derivation algorithm missing data algorithm multiple comparison strategy subgroup bridg:GovernmentFunding false GovernmentFunding Fiscal support from governmental organizations. United States National Institutes of Health (NIH) false fundingCategoryCode A coded value specifying the type of funding provided for a study. Externally Peer-Reviewed Industrial Institutional National This is as defined for the NCI Summary 4 Funding requirements. false fundingMechanismCode A coded value specifying the unique identifier for areas of extramural research activity applied to various funding mechanisms. R01 (Research Project) U10 (Cooperative Clinical Research Cooperative Agreements) false nciProgramCode A coded value specifying the organizational units within the National Cancer Insitute (NCI) (divisions, programs and offices) that provide funding. CDP (Cancer Diagnosis Program) CTEP (Cancer Therapy Evaluation Program) DTP (Developmental Therapeutics Program) false nihInstituteCode A two letter coded value specifying the first major-level subdivision of the organization that supports a grant, contract, or inter-agency agreement. The support may be financial or administrative. CP2 Division of Cancer Epidemiology and Genetics (NCI) LM National Library of Medicine (NLM) false serialNumberText A character string that represents the six-digit number generally assigned sequentially to a funding mechanism within an institute, center, or division. false typeCode A coded value specifying the kind of application received and processed. Type 1 (New) Type 5 (Noncompeting Grant Progress Report) bridg:HealthcareFacility false HealthcareFacility An organization that devotes some or all of its resources (people, places, things) to the delivery of healthcare services (including the financial and administrative management of those resources). Northwestern Memorial Hospital A healthcare facility may be manifest as a single physical location (e.g. building), or, alternatively, as a distributed collection of physical spaces. false effectiveDateRange The date (and time) span for when the healthcare facility is active. false identifier A unique symbol that establishes identity of the healthcare facility. Hospitals get an American Hospital Association (AHA) ID. In Cancer Therapy Evaluation Program (CTEP) every site that interacts with the National Cancer Institute (NCI) gets an NCI unique identifier. none false performingOrganization is a function performed by false postalAddress A contact point used to send physical forms of communication to the healthcare facility. false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the healthcare facility. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. bridg:HealthcareProvider false HealthcareProvider A person who directly or indirectly administers interventions that are designed to improve the physical or emotional status of a biologic entity. A person licensed, certified or otherwise authorized or permitted by law to administer healthcare in the ordinary course of business or practice of a profession. false effectiveDateRange The date (and time) span for when the healthcare provider is active. none false employingOrganization belong to a department at false identifier A unique symbol that establishes identity of the healthcare provider. none false performingPerson is a function performed by false postalAddress A contact point used to send physical forms of communication to the healthcare provider. none false staffedHealthcareFacility staff false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the healthcare provider. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. bridg:HealthcareProviderGroup false HealthcareProviderGroup A collection of healthcare providers loosely based upon a criterion (i.e., specialty, department, credentials). false effectiveDateRange The date (and time) span for when the healthcare provider group is active. bridg:HealthcareProviderGroupMember false HealthcareProviderGroupMember The role of an individual healthcare provider as a constituent part of a group. false effectiveDateRange The date (and time) span for when the healthcare provider group member is active. bridg:IntegratedStatisticalAnalysisPlan false IntegratedStatisticalAnalysisPlan A type of statistical analysis plan that is intended to draw conclusions across multiple studies. Plan for a meta-analysis of literature studies. Plan for integrated analysis of efficacy data in support of the Integrated Summary of Effectiveness (ISE). Plan for integrated analysis of safety data in support of the Integrated Summary of Safety (ISS). Plan for multi-study analysis to be presented in a manuscript. none false integratedStudyProtocol integrates data from Identifies the study protocols whose data is used in the integrated statistical analysis plan. bridg:InterventionalStudyProtocolVersion For blindedRoleCode, the roles identified map to StudySubject, StudyInvestigator, Assessor, and AssociatedBiologicEntity. If dataMonitoringCommitteeIndicator = "false", there must not be an associated OversightCommittee (via StudyOversightAuthority) with typeCode = "data monitoring committee". false InterventionalStudyProtocolVersion An action plan of a pre-clinical or clinical study in which study subjects or experimental units are assigned by an investigator based on a protocol to receive specific interventions. Study subjects or experimental units may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The study subjects or experimental units are then followed and biomedical and/or health outcomes are assessed. For blindedRoleCode, the roles identified map to StudySubject, StudyInvestigator, Assessor, and AssociatedBiologicEntity. blindedRoleCode Qualifier If dataMonitoringCommitteeIndicator = "false", there must not be an associated OversightCommittee (via StudyOversightAuthority) with typeCode = "data monitoring committee". dataMonitoringCommitteeIndicator Qualifier false acceptsHealthyVolunteersIndicator Specifies whether persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. false allocationCode A coded value specifying the method of assigning experimental units to treatment or control groups. n/a non-randomized study randomized controlled study false blindedRoleCode A coded value specifying the roles of individuals who are masked for single or double blind studies. caregiver investigator outcomes assessor subject false blindingSchemaCode A coded value specifying the type of masking used on a study protocol to ensure that the results are not biased by the study subjects or investigators. Double Blind Double-blinded would indicate that both the investigator and the study subject would not know whether the intervention was a placebo or an active therapeutic intervention. Open Label Single Blind false controlConcurrencyTypeCode A coded value specifying the temporal relationships of the control to the study intervention. concurrent historical pre/post (patient owned control) false controlTypeCode A coded value specifying the kind of comparison or comparator against which the study treatment is evaluated. active dose comparison historical placebo uncontrolled true dataMonitoringCommitteeIndicator Specifies whether a data monitoring committee is appointed to the study. Derived from the existence of an association between StudyProtocolVersion and StudyOversightAuthority where the associated OversightCommittee.typeCode= "data monitoring committee". false interventionDescription A character string that provides the key details of the intervention. IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.) Interventions involving drugs may include dosage form The details may distinguish between arms of a study (e.g. comparison of different dosages of drug) and/or among similar interventions (e.g. comparison of multiple implantable cardiac defibrillators). dosage frequency and duration. (50 mg/m2 false interventionGroupQuantity Number of Arms An integer specifying the number of intervention groups. Enter 1 for single-arm study. This attribute is potentially derivable once the study design has been defined. false interventionTypeCode A coded value specifying the kind of intervention being studied. Drug Lifestyle Radiation Relevant for categorization or when not conveying the details of the studied intervention. false studyAgentRandomizationFraction A number representing the quantity of study subjects in the overall study who receive at least one study agent (as opposed to placebo) divided by the quantity of subjects in the study overall - independent of dosage or other protocol variations. This value can be thought of as the percentage of study subjects who will be exposed to the study agent(s), though it is expressed as a real number with a maximum value of 1.0. bridg:Laboratory false Laboratory An organization with the capability and competency to perform scientific research, experiments and measurements. false identifier A unique symbol that establishes identity of the laboratory. Clinical Laboratory Improvement Act/Amendment (CLIA) ID none false performingOrganization be a function performed by bridg:Manufacturer false Manufacturer bridg:Material effectiveDateRange is valid only when actualIndicator = "true". false Material A physical substance. device drug specimen effectiveDateRange is valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false actualIndicator Specifies whether the material is a particular instance (actual) vs. universal kind. To indicate a particular Material actualIndicator = "false". actualIndicator = "true". To indicate a kind of Material false code A coded value specifying the non-unique textual identifier for the material. aspirin caffeine tobacco The granularity of the code may vary depending on the specificity of the material. For example, acetaminophen, Tylenol, Tylenol 250 mg gel cap. false description The textual representation of the material. false effectiveDateRange The date (and time) span for when the material is active. false formCode A coded value specifying the state and nature of the material. gas gel liquid ointment solid tablet bridg:MaterialIdentifier Only Organization with actualIndicator = "true" is valid. false MaterialIdentifier The unique identification of a material in a specific context. This class is a resolution of the requirement for noting the type of an identifier which is not handled by the purely technical HL7 II data type. Only Organization with actualIndicator = "true" is valid. be assigned by actualIndicator Qualifier none false assigningOrganization be assigned by none false identifiedMaterial identifies false identifier A unique symbol that establishes identity of the material. model number product number serial number There are multiple ways in which an identifier can be associated to a product; inherited from MaterialIdentifier.identifier, the association to ProcessedProduct.identifier, and the association to ProductRelationship.identifier. If there is no context associated with the identifier, then MaterialIdentifier.identifier should be used. However, if the identifier for a product would be different in different context, one of the other identifiers should be used. If a kind of product is produced by different processors, and each processor assigns the product a different identifier, then ProcessedProduct.identifier should be used. If the product is used in multiple assemblies, and in each assembly it would be assigned a different identifier, then ProductRelationship.identifier should be used. false typeCode A coded value specifying the kind of material identifier. bridg:MaterialName false MaterialName The non-unique textual identification of a material in a specified context. none false approvingRegulatoryAuthority be approved by false name A non-unique textual identifier for the material. The therapeutic agent used in a chemotherapy clinical trial. none false namedMaterial names false typeCode A coded value specifying the kind of material name. brand name bridg:MaterialResource false MaterialResource Physical supplies provided by an individual company, institution, or organization for the conduct of research. In kind contributions device donations of study drug etc. bridg:NotificationReceiver A Notification Receiver might be a function performed by one and only one of the following: HealthcareProvider, ReportSubmitter, DocumentAuthor, Organization, StudyPersonnel, StudySitePersonnel. false NotificationReceiver A person or organization that is the target of a notification. A Notification Receiver might be a function performed by one and only one of the following: HealthcareProvider, ReportSubmitter, DocumentAuthor, Organization, StudyPersonnel, StudySitePersonnel. be a function performed by Exclusive Or bridg:ObservationResultActionTakenRelationship false ObservationResultActionTakenRelationship AdverseEventActionTakenRelationship ProductActionTakenRelationship Specifies the link between an observation result and the actions taken as a result of that relationship An abnormal lab result triggers a follow-up lab test for further investingation. An electrical problem (product investigation result) in a device could result in a recall (product action taken) of the device. Study dose reduced or protocol treatment change due to an adverse event. Action taken relationship is generally used for "unplanned" activities rather than those already determined in "contingent" relationships in the planned study design. false delayDuration The time delay between an observation result being determined and a resulting performed activity action being taken. none false triggeredPerformedActivity triggers Indicates the PerformedActivity undertaken as a result of an ObservationResult none false triggeringPerformedObservationResult is triggered by Indicates the ObservationResult that causes the initiation of a PerformedActivity bridg:ObservationalStudyProtocolVersion false ObservationalStudyProtocolVersion An action plan of a pre-clinical or clinical study in which biomedical and/or health outcomes are assessed in pre-defined groups of study subjects or experimental units. Study subjects or experimental units in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study subjects or experimental units of the study. false samplingMethodCode A coded value specifying the process used to define a representative set of a population for a study. A Non-Probability Sample: any of a variety of other sampling processes A Probability Sample: exclusively random process to guarantee that each participant or population has specified chance of selection and consecutive patient sampling. cluster sampling stratified random sampling such as convenience sampling or invitation to volunteer. such as simple random sampling systematic sampling false specimenAvailableForDNAExtractionIndicator Specifies whether any biological specimen has the potential for DNA extraction. Specimens with the potential for DNA extraction include frozen tissue and whole blood whereas specimens without the potential for DNA extraction include fixed tissue and plasma. false specimenRetentionIndicator Specifies whether a biological specimen is retained beyond the duration of the study. false timePerspectiveCode A coded value specifying the temporal relationship of observation period to time of subject enrollment. cross-sectional other prospective retrospective bridg:Organization name, postalAddress, telecomAddress are valid only when actualIndicator = "true". false Organization A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose. ACME Corporation US National Cancer Institute (NCI); CDISC; HL7 name, postalAddress, telecomAddress are valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false actualIndicator Specifies whether the organization is a particular instance (actual) vs. universal kind. To indicate a particular Organization actualIndicator = "false". actualIndicator = "true". To indicate a kind of Organization false description The textual representation of the organization. false effectiveDateRange The date (and time) span for when the organization is active. false name A non-unique textual identifier for the organization. false postalAddress A contact point used to send physical forms of communication to the organization. false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the organization. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. false typeCode A coded value specifying the kind of organization. academic commercial government non-commercial [example from EudraCT] other pharmaceutical industry bridg:OrganizationIdentifier An OrganizationIdentifier is assigned by one and only one of the following: Organization, SystemOfRecord. Only Organization with actualIndicator = "true" is valid. false OrganizationIdentifier The unique identification of an organization in a specified context. This class is a resolution of the requirement for noting the type of an identifier which is not handled by the purely technical HL7 II data type. An OrganizationIdentifier is assigned by one and only one of the following: Organization, SystemOfRecord. be assigned by Exclusive Or Only Organization with actualIndicator = "true" is valid. be assigned by actualIndicator Qualifier Only Organization with actualIndicator = "true" is valid. identifies actualIndicator Qualifier none false assigningOrganization be assigned by none false assigningSystemOfRecord be assigned by none false identifiedOrganization identifies false identifier A unique symbol that establishes identity of the organization. In cases of laboratories this is the Clinical Laboratory Improvement Act/Amendment (CLIA) ID. false primaryIndicator Specifies whether this is the main or principal organization identifier. false typeCode A coded value specifying the kind of organization identifier. bridg:OrganizationRelationship false OrganizationRelationship Specifies the link between one organization and another. The relationship between an organization and its legal representative divisions). the whole/part relationship between an organization and its sub organizations (e.g. departments false effectiveDateRange The date (and time) span for when the organization relationship is active. none false sourceOrganization has as source none false targetOrganization has as target false typeCode A coded value specifying the kind of organization relationship. center department legal representative part This is HL7 structured vocabulary and is part of a controlled vocabulary set. bridg:OrganizationalContact Only Organization with actualIndicator = "true" is valid. Only Person with actualIndicator = "true" is valid. false OrganizationalContact A person who provides or receives information on behalf of an organization. Only Organization with actualIndicator = "true" is valid. handles communication for actualIndicator Qualifier Only Person with actualIndicator = "true" is valid. be a function performed by actualIndicator Qualifier false effectiveDateRange The date (and time) span for when the organizational contact is active. none false performingPerson be a function performed by false postalAddress A contact point used to send physical forms of communication to the organizational contact. false primaryIndicator Specifies whether this is the main or principal organizational contact. none false supportedOrganization handles communication for false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the organizational contact. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. false title A descriptive or distinctive appellation, especially one belonging to a person by right of rank, office, attainment, etc. false typeCode A coded value specifying the kind of organizational contact. Review Board contact financial manufacturing safety sales bridg:OversightAuthority false OversightAuthority An organization with monitoring, regulatory, or supervisory authority over biomedical research at the local, regional, national, or international level. Ethics committee Food and Drug Administration (FDA) in the USA Institutional Review Board (IRB) Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK Research ethics board World Health Organization (WHO) none false performingOrganization is a function performed by bridg:OversightCommittee false OversightCommittee An organization that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study subjects. This committee performs critical oversight functions for research conducted on human study subjects that are scientific, ethical, and regulatory. Institutional Review Board (IRB) ethics committee research ethics board false effectiveDateRange The date (and time) span for when the oversight committee is active. none false overseenHealthcareFacility oversee none false overseenStudySite oversee false typeCode A coded value specifying the kind of oversight committee. Adjudication Committee Data Safety Monitoring Board IRB bridg:Package false Package A container within which the product is delivered or shipped. a shipping carton bottle false capTypeCode A coded value specifying the type of container cap. film foil In some cases, it is important for this to be consistent with decapping, piercing or other automated manipulation. false capacityQuantity The maximum number of product units within a package. 1000 cc. false handlingCode A coded value specifying special handling requirements for the package. keep at room temperature store upright bridg:PerformedActivity A PerformedActivity is only directly related to a StudyProtocolVersion if it is instantiating a PlannedActivity or ScheduledActivity (not a DefinedActivity). A PerformedActivity must instantiate one and only one of the following: DefinedActivity, PlannedActivity, ScheduledActivity. Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = “true” is valid. Only Person, Organization or Device (via Performer) with actualIndicator = "true" is valid. The containing Epoch association must not be present for PerformedActivities that instantiate PlannedActivities (or ScheduledActivites that instantiate PlannedActivities) with an association to Epoch. When PerformedObservation.focalDateRange is present, PerformedObservation.dateRange must be a single date. false PerformedActivity An activity that is successfully or unsuccessfully completed. A scheduled blood draw that is missed by a specific ExperimentalUnit on a given day. CBC performed on a specific StudySubject on a given day. A PerformedActivity is only directly related to a StudyProtocolVersion if it is instantiating a PlannedActivity or ScheduledActivity (not a DefinedActivity). occurs in the context of Qualifier A PerformedActivity must instantiate one and only one of the following: DefinedActivity, PlannedActivity, ScheduledActivity. instantiates Exclusive Or Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = “true” is valid. be participated in by actualIndicator Qualifier Only Person, Organization or Device (via Performer) with actualIndicator = "true" is valid. be performed by actualIndicator Qualifier The containing Epoch association must not be present for PerformedActivities that instantiate PlannedActivities (or ScheduledActivites that instantiate PlannedActivities) with an association to Epoch. containingEpoch Qualifier When PerformedObservation.focalDateRange is present, PerformedObservation.dateRange must be a single date. dateRange Qualifier none false containingEpoch be contained by Indicates that a performed but unplanned activity is categorized as part of a particular Epoch. This cannot be derived by looking at the corresponding planned activity because this association is only used for unplanned activities. false dateRange The date and time span when this activity began and ended. A dose of chemotherapy is given on June 12th starting at 9am and finishing at 12pm. The date and time when a sample is taken from the subject. Whether administrative or preparatory activities are included in this time frame is up to whoever is defining the activity - this time frame is all that matters when the activity occurred. The date range is an interval (IVL) data type, meaning it has a beginning (low) and end (high) values. It is also a datetime (TS.DATETIME) data type, meaning the beginning date and the end date can have uncertain values (e.g., a range). For example, if a subject was diagnosed with leukemia sometime in 2009 and that subject had a transplant (substance administration) sometime in 2010. We can surmise that the subject must have had a preparative regimen sometime between those times. Therefore the preparative regimen activity would have a beginning (low) date range of between 2009-01-01 and 2009-12-31; and an ending (high) date range of between 2010-01-01 and 2010-12-31. The precise data type mappings would be: IVL<TS.DATETIME>.low.uncertainRange.low = 2009-01-01 IVL<TS.DATETIME>.low.uncertainRange.high = 2009-12-31 IVL<TS.DATETIME>.high.uncertainRange.low = 2010-01-01 IVL<TS.DATETIME>.high.uncertainRange.high = 2010-12-31 [Note that times are left out of the example to keep it as simple as possible.] false dateRangeValidationCode A coded value specifying the degree of authoritativeness or certiitude of the date of the activity date estimated date greater than 100 days - day is correct date known date less than 100 days - date is correct date previously reported The concept of "date unknown" is captured by a nullFlavor of "UNK" on the dateRange attribute, rather than a code in this attribute. true delayDuration The period of time that an action is delayed relative to an original schedule. If a substance administration is delayed 2 days as a result of an adverse event then the delayDuration is 2 days. Derived from comparing the dates of the scheduled activity with the corresponding performed activity. true duration The period of time over which the activity is performed. Derived from the notion of duration in the IVL (width) portion of the dateRange attribute. true fastingStatusIndicator Specifies whether the participant had abstained from eating when the specimen is obtained. Derived from the presence of a PerformedObservation ("Was the subject fasting when the specimen collection was performed?") and associated PerformedObservationResult.value (constrained to a BL with value of "true") related to a PerformedSpecimenCollection. The PerformedObservation would be related to the PerformedSpecimenCollection by both being components of the same composite activity such as a visit (DefinedSubjectActivityGroup or PlannedSubjectActivityGroup). none false instantiatedDefinedActivity instantiate none false instantiatedPlannedActivity instantiate none false locatingPlace take place in true medicalHistoryIndicator Specifies whether the activity is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study. Derived from comparing the date range of the activity (PerformedActivity.dateRange) with the subject participation in the study (PerformedStudySubjectMilestone.studyReferenceDateRange). If the date is within the study participation date range then this indicator will be "false". Note that this means that this indicator will be derived differently for each study. false negationIndicator Specifies whether an activity did not occur. If a subject did not take aspirin in the previous week the negationIndicator = "true". If it is important to capture the fact that a particular activity did not occur, then this attribute is used, often along with negationReason. false negationReason The text and/or code that describes why an activity did not occur. forgot to ask sample lost true repetitionNumber An integer that identifies the particular occurrence of a repeating activity. The first repetition is defined as '1'. 2 3 A PlannedActivity might have a repeatQuantity of 4 which would result in 4 ScheduledActivity and PerformedActivity with repetitionNumbers of 1 and 4 respectively. Derived from ScheduledActivity.repetitionNumber. false statusCode A coded value specifying the phase in the lifecycle of a performed activity. "canceled" "completed" For a lab test etc.). this would be the condition or stage in the lifecycle of the test (e.g. Please refer to the Performed Activity Status state transition diagram for further details. false statusDate The date (and time) on which the status is assigned to the activity. true studyDayRange Study Day The relative timing for a performed activity expressed as the number of days offset from the study-defined reference activity (e.g., date of registration, start of treatment) for this particular experimental unit. Day 1 Days 10-20 Derived from the dateRange of this activity minus the dateRange of the reference activity + 1. The study-defined reference activity can be different from study to study. The study day for a date after this reference activity is a positive integer calculated as the difference in the two dates + 1. The study day for dates before the reference activity is a negative integer calculated as the difference between the two dates. Note that this means there is no "Day 0." none false versionStudyProtocolVersion execute under bridg:PerformedAdministrativeActivity Only Organization (via StudySite) with actualIndicator = "true" is valid. false PerformedAdministrativeActivity The completed action within the context of a given study that is not directly related to the study's overarching hypothesis evaluation or testing, but is nonetheless essential to the efficient and/or effective coordination and execution of the study. assignment to a treatment arm break treatment blind complete study visits end of on-study period enroll etc. exit study obtain informed consent premature withdrawal protocol violation randomize registration to a study start of on-study period verify eligibility criteria Only Organization (via StudySite) with actualIndicator = "true" is valid. be performed at actualIndicator Qualifier none false performingStudySite be performed at false varianceReasonCode A coded value specifying why what occurred is different from what was expected. Subject received early treatment because of vacation plans. false varianceTypeCode A coded value specifying the kind of variance. early / late occurrence of an act higher / lower amount transferred bridg:PerformedClinicalInterpretation Only one of the following attributes will be populated in any given instance: toxicityGradeCode, severityCode, clinicallySignificantIndicator, abnormalIndicator. false PerformedClinicalInterpretation An assessment which involves determining the meaning of one or more other observation results. The results of a white blood cell count may be interpreted as constituting a grade 2 toxicity. Only one of the following attributes will be populated in any given instance: toxicityGradeCode, severityCode, clinicallySignificantIndicator, abnormalIndicator. Derived Attribute Exclusive Or true abnormalIndicator Specifies whether an interpreted event is abnormal. Derived from PerformedClinicalInterpretation.value(ANY=>CD).code WHERE PerformedObservationResult.typeCode = "assess abnormality". true clinicallySignificantIndicator Specifies whether a subject's clinical condition is important based on judgment. Derived from PerformedClinicalInterpretation.value(ANY=>BL) WHERE PerformedClinicalInterpretation > PerformedObservation > DefinedObservation.nameCode = "assess clinical significance". true severityCode A coded value specifying the intensity of the interpreted event. Moderate could be used to describe acne. Derived from PerformedClinicalInterpretation.value(ANY=>CD).code WHERE PerformedClinicalInterpretation > PerformedObservation > DefinedObservation.nameCode = "assess severity". true toxicityGradeCode A coded value specifying the numeric grade for the toxicity. Derived from PerformedClinicalInterpretation.value(ANY=>CD).code WHERE PerformedObservationResult > PerformedObservation > DefinedObservation > DefinedObservationResult.typeCode = "toxicity grade code" Similar to Common Toxicity Criteria Toxicity Grade false toxicityTermCode A coded value specifying the degree to which a substance is able to damage an exposed organism. hypocalcaemia Similar to CTC Term (short name), e.g., the National Cancer Institute's Common Toxicity Criteria terminology. bridg:PerformedClinicalResult If a PerformedClinicalResult references a ReferenceResult, it is required that PerformedClinicalResult.typeCode = ReferenceResult.valueTypeCode. It is further required that the fastingStatusIndicator on the PerformedSpecimenCollection that produced the specimen upon which the clinical test was performed = ReferenceResult.fastingStatusIndicator if specified. false PerformedClinicalResult A result of a clinical observation, i.e. from an examination, test or direct observation performed on the experimental unit. The performed observation of "WBC count" would be associated to a clinical result called "WBC result" in which the results of the observation (7500 WBCs) would be stored. There is an association between the observation that has the original data (and the original units) and the observation in which the data elements have been converted into standardized units. If further use case are discovered it may be necessary to move the recursive relationship up to PerformedObservationResult. If a PerformedClinicalResult references a ReferenceResult, it is required that PerformedClinicalResult.typeCode = ReferenceResult.valueTypeCode. It is further required that the fastingStatusIndicator on the PerformedSpecimenCollection that produced the specimen upon which the clinical test was performed = ReferenceResult.fastingStatusIndicator if specified. reference Qualifier false asCollectedIndicator Specifies whether the observation is represented in the units or values as originally collected. A performing lab may have completed the observation or lab test using conventional units and "false" on the lab test in which the units that are different than the lab test's original units. but the sponsor may wish to have the test reported in SI units. This flag will be set to "true" on the lab test that has the original units false biomarkerIndicator Specifies whether a result is considered a biomarker. This attribute is based on a result as stated in the NCI Thesaurus for Biomarker: A variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. Biomarkers include but not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substances. none false convertedPerformedClinicalResult be converted into true infectiousAgent The name of the specific microbe that the test is intended to identify. staphylococcus aureus streptococcus pneumoniae Derived from PerformedObservation directly or indirectly linked to DefinedActivity.nameCode(CD).originaltext. true normalRangeComparisonCode A coded value specifying the relationship of a value to a normal range or reference range of values. high low outside normal range within normal range Derived from comparing PerformedObservationResult.value to the ReferenceResult.value. none false referencedReferenceResult reference false statusCode A coded value specifying the phase in the lifecycle of the reported result. corrected final preliminary bridg:PerformedCompositionRelationship The PerformedCompositionRelationship class may only be used when there is no DefinedCompositionRelationship or PlannedCompositionRelationship between the objects that the source and target relationship instantiate (directly or indirectly). I.e., if the composition relationship can reasonably be expressed in the defined or planned representation, it must be expressed there, not in the performed representation. false PerformedCompositionRelationship A relationship between a composite activity and a component activity that comprises it, i.e. parent and child activities where all activities have occurred in the context of a particular study. A planned substance administration occurs as part of an encounter that is different than the one in which it was originally planned. An unplanned encounter contains a number of activities. An unplanned substance administration occurs as part of a planned encounter. Particularly relevant when one or both of the activities are not planned as the composition relationship can't be established using the normal PlannedCompositionRelationship or DefinedCompositionRelationship. The PerformedCompositionRelationship class may only be used when there is no DefinedCompositionRelationship or PlannedCompositionRelationship between the objects that the source and target relationship instantiate (directly or indirectly). I.e., if the composition relationship can reasonably be expressed in the defined or planned representation, it must be expressed there, not in the performed representation. Composition Relationship Qualifier bridg:PerformedDiagnosis false PerformedDiagnosis The identification of a disease or illness by examining the signs and symptoms. false bodySystemCode A coded value specifying the anatomical structure that consists of organs and organ subclasses responsible for certain body functions. gastrointestinal system hematopoietic system urinary system false diseaseStatusCode A coded value specifying the amount of disease present in a subject. metastatic and disease-free (cancer-specific examples) false diseaseStatusMissingReasonCode A coded value specifying why a disease status is missing. "the sample was damaged" is a reason code within the "unevaluable" classification. The distinctions between unevaluable, missing reason and not assessed, will be made in the hierarchy of the reason codes and need not be made as distinct attributes, since they are mutually exclusive. This value should only be populated if PerformedDiagnosis.diseaseStatusCode is null. false recurrenceIndicator Specifies whether this is a reappearance of the existing disease. bridg:PerformedDiagnosisProcedureRelationship false PerformedDiagnosisProcedureRelationship Specifies the link between a diagnosis and the procedure performed to address it. bridg:PerformedEligibilityCriterion Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. false PerformedEligibilityCriterion One of a set of conditions that a study subject must meet in order to participate in a study. Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier false displayOrder The sequence or position of a component in a list of question or data items. false notApplicableIndicator Specifies whether the specific eligibility criterion is not applicable to this participant. bridg:PerformedExclusionCriterion false PerformedExclusionCriterion A characteristic or requirement that disqualifies a subject from participation in a study. pregnancy bridg:PerformedExperimentalUnitAllocation Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid. false PerformedExperimentalUnitAllocation The completed action that is the assignment of an experimental unit to a portion of the study, such as an arm or a portion of an arm (when secondary allocations may occur). Mrs. Smith is assigned to Arm A. Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid. be participated in by Qualifier none false assignedArm assign a subject to bridg:PerformedHistopathology false PerformedHistopathology The findings from a microscopic study of characteristic tissue abnormalities by employing various cytochemical and immunocytochemical stains. false differentiationGradeCode A coded value specifying the degree of cellular differentiation in a tissue sample. A brain tumor could be grade 3 false involvedSurgicalMarginIndicator Specifies whether the margins of surgical resection are infiltrated by the abnormal tissue. bridg:PerformedImaging Associations from Subject (including StudySubject) and Experimental Unit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, not for Product, ProductGroup, Organization or HealthcareFacility. false PerformedImaging The completed action of obtaining pictures of the interior or exterior of the body usually for diagnostic reasons. MRI X-ray etc Associations from Subject (including StudySubject) and Experimental Unit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, not for Product, ProductGroup, Organization or HealthcareFacility. be participated in by Qualifier false contrastAgentEnhancementIndicator Specifies whether the image is enhanced by the use of a contrast agent. false enhancementDescription The textual representation for how an image is enhanced either physically or electronically. false enhancementRate The numeric value to indicate an increase in voxel signal over time for an MRI, expressed as signal intensity units per second. bridg:PerformedInclusionCriterion false PerformedInclusionCriterion A characteristic or requirement that a subject must meet to participate in a study. Must be over the age of 18 bridg:PerformedLesionDescription false PerformedLesionDescription A characterization of the extent of any localized or abnormal change in the structure of part of an organ or tissue. false appearanceTypeCode A coded value specifying the appearance of a superficial lesion. flat nodular false contactAnatomicSiteCode A coded value specifying the anatomic site (single) in contact with the lesion. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. true dimensionProduct The result or product of multiplying dimensions (2 or 3) of a site or specimen. Derived from multiplying at least two (2) of the following: PerformedLesionDescription.xDimension, PerformedLesionDescription.yDimension, PerformedLesionDescription.zDimension. false lesionNumber The integer assigned to a lesion for a subject. Once a lesion number is designated for a specific lesion that number may not change or re-used to denote a different lesion. false measurableIndicator Specifies whether a lesion or site of disease is measurable. false xDimension The measurement of a lesion or location in the 'X' (first or length) dimension. This is the longest measurement or largest value if only one measurement is captured. false yDimension The measurement of a lesion in the 'Y' (second or width) dimension. false zDimension The measurement of a lesion in the 'Z' (third) dimension. bridg:PerformedMaterialProcessStep Associations from Subject (including StudySubject) and ExperimentalUnit are valid for Specimen, Product and ProductGroup, not for BiologicEntity, BiologicEntityPart, BiologicEntityGroup, HealthcareFacility or Organization. false PerformedMaterialProcessStep product manipulation The completed act of processing a material. adding additives or growth factors aliquot dividing embedding freezing spinning thawing Material process may be performed on any kind of material, such as a specimen, nanomaterial, or biologic. The result of the process may a similar or different kind of material, for instance a specimen may be the result of a specimen processing step (e.g., aliquot or division of a specimen), or alternatively a blood product has anticoagulants added to it to preserve the product. Other processsing steps, such as adding growth factor to induce cell growth, may be performed on the blood product. Associations from Subject (including StudySubject) and ExperimentalUnit are valid for Specimen, Product and ProductGroup, not for BiologicEntity, BiologicEntityPart, BiologicEntityGroup, HealthcareFacility or Organization. be participated in by Qualifier false standardTimeIndicator Specifies whether the time of the process step is specified using standard (as opposed to daylight savings) time. If the location and date are known, this data is derivable. bridg:PerformedMaterialStorage Associations from Subject (including StudySubject) and ExperimentalUnit are valid for Specimen and Product, not for BiologicEntity, BIologicEntityPart, BiologicEntityGroup, ProductGroup, HealthcareFacility or Organization. false PerformedMaterialStorage The completed action of safekeeping harvested material in a depository. cryopreservation dehydration etc. refrigeration There is a difference between the act of changing the state of material, which is represented by PerformedMaterialProcessStep, and the act of maintaining state of the material by storing it, which is represented by PerformedMaterialStorage. Associations from Subject (including StudySubject) and ExperimentalUnit are valid for Specimen and Product, not for BiologicEntity, BIologicEntityPart, BiologicEntityGroup, ProductGroup, HealthcareFacility or Organization. be participated in by Qualifier false methodCode A coded value specifying the technique that is used to store the material. electric freezer liquid nitrogen vapor phase false temperatureRange The thermal reading at which the storage unit was set. >= -80 degrees celsius < -150 degrees celsius -135 to -80 degrees celsius -150 to -135 degrees celsius bridg:PerformedMedicalConditionResult false PerformedMedicalConditionResult Clinical Events Medical History Any sign, symptom, disease, or other medical occurrence. back pain broken bone death depression flu headache heart attack menstrual period pregnancy pulmonary embolism This condition may have been recalled by the subject or a caregiver or provided in their medical record. true clinicallySignificantIndicator Specifies whether a subject's clinical condition is important based on judgment. Derived from PerformedClinicalInterpretation.value(ANY=> BL) WHERE PerformedClinicalInterpretation > PerformedObservation > DefinedObservation.nameCode = "assess clinical significance". false endRelativeToReferenceCode A coded value specifying the end of the medical condition event with respect to the sponsor-defined reference period. after before during during/after Derived from comparing PerformedSubstanceAdministration.dateRange(IVL<TS.DATETIME>).high and PerformedStudySubjectMilestone.studyReferenceDateRange. Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected. true medicalHistoryIndicator Specifies whether the condition is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study. Derived from the medical history indicator on the activity (PerformedActivity.medicalHistoryIndicator) which produced this result. false occurrenceDateRange Onset date duration. resolution date The date and time span in which the medical condition began and ended. These may be partial dates or durations (duration is the width property of the IVL<TS> datatype). A condition may be considered to have ended when a subject returns to their baseline state. false occurrenceDateRangeValidationCode A coded value specifying the degree of authoritativeness or certitude of the occurrence date. "date > 100 days "date < 100 days "date estimated" date is correct" The concept of "date unknown" is captured by a nullFlavor of "UNK" on the dateRange attribute, rather than a code in this attribute. A patient might have recovered from neutrophil in the past, but isn't sure of the exact date and state "I think it was in January of 2005". This would be recorded with an occuranceDateRange of "January 2005" and an uncertainOccuranceDateCode of "estimated". false severityCode A coded value specifying the intensity of the condition. Moderate could be used to describe acne. Values of: none mild or trivial moderate or severe unknown could be used for a aorta valvular insufficiency valve replacement Derived from PerformedClinicalInterpretation.value(ANY=>CD) WHERE PerformedClinicalInterpretation > PerformedObservation [severity assessment] > DefinedObservation.nameCode = "assess severity" AND PerformedObservation [severity assessment] > AssessedResultRelationship > PerformedMedicalConditionResult bridg:PerformedNotification Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. Only Person or Organization (via NotificationReceiver) with actualIndicator = "true" is valid. false PerformedNotification The completed action within the context of a given study that represents the communication of a message to a recipient. Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only Person or Organization (via NotificationReceiver) with actualIndicator = "true" is valid. be received by actualIndicator Qualifier false message The actual text that was included in the notification. false messageTitle The subject of the notification. bridg:PerformedObservation A PerformedObservation is reported by an Assessor. The inherited association of Performer (from Activity) is not valid for a PerformedObservation. Only Organization (via PerformingLaboratory) with actualIndicator = "true" is valid. Only Person, Device or Organization (via Assessor) with actualIndicator = "true" is valid. false PerformedObservation The completed action of observing, monitoring, measuring or otherwise qualitatively or quantitatively gathering data or information about one or more aspects of a subject, study subject, or experimental unit. lab test physical exam taking vital signs A PerformedObservation is reported by an Assessor. The inherited association of Performer (from Activity) is not valid for a PerformedObservation. be reported by Qualifier Only Organization (via PerformingLaboratory) with actualIndicator = "true" is valid. be performed by (lab) actualIndicator Qualifier Only Person, Device or Organization (via Assessor) with actualIndicator = "true" is valid. be reported by actualIndicator Qualifier false approachAnatomicSiteCode A coded value specifying the anatomic location or access point for an observation. Anus for a colonoscopy observation Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is the acces point for the measurement or observation and the target site is what is ultimately being evaluated. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false approachAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is an access point for a observation. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. false bodyPositionCode A coded value specifying the 3-dimensional spatial orientation of a subject during a particular observation. standing supine trendelenburg false bodySystemCode A coded value specifying the anatomical structure that consists of organs and organ subclasses responsible for certain body functions. gastrointestinal system hematopoietic system urinary system none false commentedPerformedActivity be commenting on none false commentedSafetyReportVersion be commenting on true focalDateRange The time period in which the observation result is held to be true. Derived from DefinedObservation.focalDateRange alone (i.e., directly from simple date ranges like 1990-1999) or from evaluating the expression in DefinedObservation.focalDateRange (which references a date that is now known). true focalDuration The quantity of time in which the observation result is held to be true. 2 months is the focalDuration for a question such as "Have you smoked in the last 2 months?". Derived from PerformedObservation.focalDateRange. false methodCode A coded value specifying the technique used to perform the observation. Arterial puncture Estrogen Receptor Assay Global introspection Progesterone Receptor Assay algorithm bayesian (for Adverse Event causality) p53 Assay (for clinical result assay) sphygmomanometry (for blood pressure measurement) none false performingPerformingLaboratory be performed by none false reportingAssessor be reported by false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of the observation. Lower intestine for a colonoscopy observation The target site of the result may be different than the target site of the activity (PerformedObservation) that generated it. For example, a chest x-ray (observation) has the target site of chest while the result might show an infiltration in the left lower lobe of the lung (target site of result), or a dermatological exam may check the skin across the whole body (target site of observation) while the result might identify a rash on the right leg (target site of result). Neither target anatomic site nor approach anatomic site is necessarily required or relevant for certain observations, however if either or both are present then the distinction between them is that the approach site is where the measurement or observation is performed and the target site is what is ultimately being evaluated. The target site is often implicit in the definition of the observation itself. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for an observation. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. bridg:PerformedObservationResult false PerformedObservationResult The finding obtained by observing, monitoring, measuring or otherwise qualitatively or quantitatively recording one or more aspects of physiologic or psychologic processes. false baselineIndicator Specifies whether the result is a starting point to which other results may be compared. false comment Additional description of the observation result. Comments from the investigator regarding the condition of the specimen or any other observation. Comments in addition to the specimen condition from the central or performing laboratory describing the specimen. false confidentialityCode A coded value specifying the degree of privacy applicable for the observation result. Do not reveal to study sponsor. false identifier The unique symbol that establishes identity of the observation result. none false infersPerformedObservationResult be inferred from none false producingPerformedObservation is a result of false reportedDate The date (and time) on which the result is reported. false resultClassificationCode System Organ Class The highest level of the terminology describing the result distinguished by anatomical or physiological system, etiology, or purpose. Blood and lymphatic system disorders; Cardiac disorders; Congenital familial and genetic disorders; Ear and labyrinth disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders and administration site conditions; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Injury malignant and unspecified (incl cysts and polyps); Nervous system disorders; Pregnancy poisoning and procedural complications; Investigations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign puerperium and perinatal conditions; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Social circumstances; Surgical and medical procedures; Vascular disorders Note that the DSET data type means that more than one value can be specified for this attribute, however this is meant to be interpreted as more than one system, etiology or purpose, such as when a CRF has "check all that apply" instruction. This is not meant to imply that there would be more than one level of terminology or some sort of hierarchy of terms would be conveyed here. false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for an observation result. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. false typeCode A coded value specifying the kind of observation result. A single blood pressure observation has two results typeCode = "systolic" and typeCode = "diastolic". false uncertaintyCode A coded value specifying whether and to what degree this evaluation or observation has been asserted to be in doubt in any way. A patient might have had a cholecystectomy procedure in the past but isn't sure what the outcome was. false value Data or information that is determined by an act of observation. The adverse event term code. The result of a lab test physical finding self-reported symptom. false valueCodeModifiedText A character string that is a revision of the original text observation result to enable the coding of the text. If the originalText is "hedache" so that the text can be successfully coded. the valueCodeModifiedText could be changed to "headache" In the context of BRIDG, text modification occurs a single time for a given instance of originalText. false valueNullFlavorReason The text and/or code that describes why no result was provided. Error message returned by equipment to explain why the device was unable to produce a result. Subject refused to answer question. This value should only be populated if PerformedObservationResult.value is null. bridg:PerformedProcedure Only Product with actualIndicator = "true" is valid. false PerformedProcedure The completed action whose immediate and primary intention is the alteration of the physical or mental condition of the subject, study subject or experimental unit. Procedures may involve the disruption of some body surface (e.g. an incision in a surgical procedure) conservative procedures such as reduction of a luxated joint acupuncture balneotherapy counseling etc. including physiotherapy such as chiropractic treatment massage shiatsu Only Product with actualIndicator = "true" is valid. uses actualIndicator Qualifier false approachAnatomicSiteCode A coded value specifying the anatomic location or access point for a procedure. Arm for an injection trans-abdominal for a nephrectomy. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false approachAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is an access point for a procedure. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. false methodCode A coded value specifying the technique that is used to perform the procedure. Abdominal/ ascites effusion Biopsy Bronchial alveolar lavage (BAL) (for specimen collection) Finger stick Open laparoscopic (for cholecystectomy) veni puncture false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of a procedure. Kidney (or a nephrectomy) Multiple contiguous sites within the same organ system may be referenced. Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false targetAnatomicSiteConditionCode A coded value specifying the state of the target anatomic site. The subject's left arm was bruised where the IV was inserted. false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for a procedure. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. none false triggeringPerformedObservationResult be recorded as a result of none false usedProduct use bridg:PerformedProductInvestigation A PerformedProductInvestigation is triggered by one and only one of the following: AdverseEvent, PerformedProductProblemDiscovery. Associations from Subject (including StudySubject) are valid only for Product, not for BiologicEntity, BiologicEntityGroup, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. false PerformedProductInvestigation The completed process of evaluating a product after it has been returned to the manufacturer or reprocessor. A PerformedProductInvestigation is triggered by one and only one of the following: AdverseEvent, PerformedProductProblemDiscovery. is triggered by Exclusive Or Associations from Subject (including StudySubject) are valid only for Product, not for BiologicEntity, BiologicEntityGroup, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. be participated in by Qualifier none false triggeringAdverseEvent is triggered by none false triggeringPerformedProductProblemDiscovery is triggered by bridg:PerformedProductInvestigationResult false PerformedProductInvestigationResult Information captured while conducting research on a product. An electrical problem in a device. false conclusion A text or otherwise formatted description of the final results drawn from the investigation. false defectTypeCode A coded value specifying the kind of device-related events that characterize the reported event/problem. malfunction false deviceMalfunctionCode A coded value specifying the defect or malfunction that occurred during use of the suspect device whether or not the problem is associated with an adverse event. Codes are FDA CDRH device codes. false evaluationConclusionCode A coded value specifying the relevant fact within the context of the evaluation final results for a reported suspect medical device. Based on FDA CDRH Conclusion Codes. bridg:PerformedProductProblemDiscovery false PerformedProductProblemDiscovery The recognition of a product defect that needs to be reported. An imaging device is discovered to be leaking radiation. This was discovered on Jan. 10th but it suspected to have been leaking for a week. This element maps to the ProductDefectDiscovery class in ICSR and maps to the MedWatch Form 3500A section B1 (Product problem checkbox). The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every PerformedProductProblemDiscovery be described by a SafetyReportVersion. none false involvedProduct focuses on bridg:PerformedProductTransport Associations from Subject (including StudySubject) are valid for Product, not for BiologicEntity, BiologicEntityGroup, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. At least the origin or destination ServiceDeliveryLocation must be known for a PerformedProductTransport. Only Organization (via ServiceDeliveryLocation) with actualIndicator = "true" is valid. false PerformedProductTransport A completed action of transporting a product between a point of origin and a point of destination. Delivery of drugs from the manufacturer to a medical facility. Associations from Subject (including StudySubject) are valid for Product, not for BiologicEntity, BiologicEntityGroup, Specimen, HealthcareFacility or Organization. Associations from ExperimentalUnit are not valid. be participated in by Qualifier At least the origin or destination ServiceDeliveryLocation must be known for a PerformedProductTransport. ServiceDeliveryLocation Qualifier Only Organization (via ServiceDeliveryLocation) with actualIndicator = "true" is valid. have destination actualIndicator Qualifier Only Organization (via ServiceDeliveryLocation) with actualIndicator = "true" is valid. originates at actualIndicator Qualifier none false destinationServiceDeliveryLocation have destination false methodCode A coded value specifying the technique that is used to transport the product. frozen gel pack room temperature per transplant center request none false originServiceDeliveryLocation originate at false standardTimeIndicator Specifies whether the time of the product transport is specified using standard (as opposed to daylight savings) time. If the location and date are known, this data is derivable. bridg:PerformedProtocolDeviation Only Person (via StudyResearchCoordinator) with actualIndicator = "true" is valid. Only Person (via StudySitePersonnel) with actualIndicator = "true" is valid. Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid. false PerformedProtocolDeviation A designation of an event as a variation from process or procedures defined in a study protocol. Study subject not withdrawn as per protocol excluded concomitant medication treatment deviation. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety. Only Person (via StudyResearchCoordinator) with actualIndicator = "true" is valid. be managed by actualIndicator Qualifier Only Person (via StudySitePersonnel) with actualIndicator = "true" is valid. be addressed by actualIndicator Qualifier Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid. be authorized by actualIndicator Qualifier none false authorizingStudyLegalSponsor be authorized by false categoryCode A coded value specifying a classification of protocol deviation. Concomitant Medications Data Integrity Compromised Eligibility not checked Eligibility waiver Informed Consent Other specify Study Procedures Treatment [NCI CRF Standard examples] false occurrenceDateRange The date and time span specifying when the protocol deviation began and ended. false severityCode A coded value specifying the intensity of a protocol deviation. major minor moderate false subcategoryCode A coded value specifying a subdivision within a larger category of a protocol deviation. bridg:PerformedSpecimenCollection Only Material (via Specimen) with actualIndicator = “true” is valid. Only Organization (via CollectingLaboratory) with actualIndicator = "true" is valid. false PerformedSpecimenCollection The completed action of gathering samples that may be used for subsequent analysis. blood draw Only Material (via Specimen) with actualIndicator = “true” is valid. results in actualIndicator Qualifier Only Organization (via CollectingLaboratory) with actualIndicator = "true" is valid. be performed by (lab) actualIndicator Qualifier bridg:PerformedStudyAdministrativeActivity Associations from Subject (including StudySubject) and ExperimentalUnit are not valid. false PerformedStudyAdministrativeActivity The completed study level administrative activity that is independent of a study subject. FDA audit IRB Approval site enrollment Associations from Subject (including StudySubject) and ExperimentalUnit are not valid. be participated in by Not Applicable bridg:PerformedStudyAgentTransfer Associations from Product are valid only for Products that are associated to StudyAgent with the same StudyProtocolVersion as the StudyProtocolVersion associated to the PerformedStudyAgentTransfer. Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. Only Person (via StudySiteResearchCoordinator) with actualIndicator = "true" is valid. Only Product with actualIndicator = "true" is valid. false PerformedStudyAgentTransfer The completed action in which an authorized party at a designated study site dispenses or receives a study agent to/from a study subject. StudySubject receives a bottle of pills. Original units can be derived from the translation attribute of the PQ data type on PerformedStudyAgentTransfer.quantity. The term "study agent" only pertains within the context of a given study. To make this explicit in BRIDG it was determined that the StudyAgent class would only be used to connect Product to StudyProtocolVersion. All activity-related classes would be associated directly to Product to avoid the issues of activities that may cross study boundaries. To determine if a given activity uses a study agent one need only compare the product used in the activity with the list of products associated to StudyAgent for a given StudyProtocolVersion. It should be noted that this determination could be different for different studies and could evolve over the course of a given study. Associations from Product are valid only for Products that are associated to StudyAgent with the same StudyProtocolVersion as the StudyProtocolVersion associated to the PerformedStudyAgentTransfer. is a transfer of Qualifier Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only Person (via StudySiteResearchCoordinator) with actualIndicator = "true" is valid. be authorized by actualIndicator Qualifier Only Product with actualIndicator = "true" is valid. is a transfer of actualIndicator Qualifier true originalQuantity The amount and unit of study agent transferred in original units. Original units can be derived from the translation attribute of the PQ data type PerformedStudyAgentTransfer.quantity. false quantity The amount and unit of study agent transferred in standard or canonical units. none false transferredProduct is a transfer of bridg:PerformedStudySubjectMilestone Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. Only one of the date attributes will be populated in any given instance. false PerformedStudySubjectMilestone The completed action which marks a common administrative landmark for a study subject in the course of a study. assignment to a treatment arm break treatment blind complete study visits end of on-study period enroll exit study obtain informed consent premature withdrawal randomize registration to a study start of on-study period verify eligibility criteria Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only one of the date attributes will be populated in any given instance. Date Exclusive Or true informedConsentDate The date (and time) the study subject gives official consent by signing the official consent form. Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity > DefinedActivity.nameCode = "obtain informed consent". true informedConsentIndicator Specifies whether the study subject gave official consent by signing the official consent form. Derived from the existence of PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity > DefinedActivity.nameCode = "obtain informed consent". true offStudyDate The date (and time) when the study subject is removed from the study. The subject is not being followed and will not be retreated. Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity > DefinedActivity.nameCode = "remove subject from study". true offStudyReasonCode A coded value specifying why the subject is removed from a study. patient died Derived from PerformedStudySubjectMilestone.reasonCode WHERE PerformedActivity > DefinedActivity.nameCode = "remove subject from study". true registrationDate The date (and time) the subject has been registered to the study assuming they have finished screening and have been found eligible. Derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity > DefinedActivity.nameCode = "register subject". true studyReferenceDateRange The date and time span used to indicate the start and end of the study for a subject. Derived in two parts. The start date is derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity > DefinedActivity.nameCode = "first intake of agent". The end date is derived from PerformedStudySubjectMilestone.dateRange WHERE PerformedActivity > DefinedActivity.nameCode = "last intake of agent". These dates are required for all randomized subjects; null for screen failures (if screen failures are submitted). none false usedDocumentVersion use bridg:PerformedSubstanceAdministration Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. PerformedSubstanceAdministration.substanceUnknownIndicator must = "false" if an association from this procedure to a product exists. activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. Otherwise, it would be ambiguous to which active ingredient the amounts indicated in these attributes apply. endRelativeToReference must not logically precede the startRelativeToReference. For example, if startRelativeToReference is "during", endRelativeToReference must not be "before". productDose, periodProductDoseTotal, treatmentVehicleAmount, activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a single StudyAgent. Otherwise, it would be ambiguous to which agent the amounts indicated in these attributes apply. false PerformedSubstanceAdministration The completed action of applying, introducing or otherwise giving medications or other substances to the subject or experimental unit. An experimental unit who receives methotrexate as part of chemotherapy For a SubstanceAdministration approachAnatomicSiteCode = groin radiation therapy. routeOfAdministrationCode = intra-arterial. targetAnatomicSiteCode = coronary artery Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. be participated in by Qualifier PerformedSubstanceAdministration.substanceUnknownIndicator must = "false" if an association from this procedure to a product exists. substanceUnknownIndicator Qualifier activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. Otherwise, it would be ambiguous to which active ingredient the amounts indicated in these attributes apply. Active Ingredient Qualifier endRelativeToReference must not logically precede the startRelativeToReference. For example, if startRelativeToReference is "during", endRelativeToReference must not be "before". relativeToReference Qualifier productDose, periodProductDoseTotal, treatmentVehicleAmount, activeIngredientDose, periodActiveIngredientDoseTotal must only be used when the PerformedSubstanceAdministration is associated to a single StudyAgent. Otherwise, it would be ambiguous to which agent the amounts indicated in these attributes apply. Dose Qualifier true activeIngredientDose The quantity of active ingredients used in a substance administration. 5 mg Derived by multiplying the PerformedSubstanceAdministration.productDose (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "true"). false activeIngredientDoseDescription The textual representation of active ingredients in the dosing amounts or a range of dosing information used in a substance administration. 200-400 This is used for more complex dosages such as scaling and tapering doses, uncertain dosage ranges, differing morning and evening doses and other instructions that can't be expressed with a simple PQ. none false addressedPerformedMedicalConditionResult address false changeReason The rationale for changing the substance administration in relation to the previous substance administration. Dose reduced due to hematologic toxicity false changeTypeCode A coded value specifying the modification of the substance administration in relation to the previous substance administration. Agent Added Agent Dose Decreased Agent Dose Increased false distinctProductCount The number of products (resulting from different collections) used for this substance administration. If blood is taken from 2 people (two donations from one of them) this would be counted as 3 different collections. This is a count of distinct donations, typically used for stem cell transplants. false doseFrequencyCode A coded value specifying how often doses are administered. BID QID TID This attribute is needed in order to capture multiple substance administrations in one act, rather than each time a patient swallows a pill, for example "The patient took med X 3 times a day for 10 days starting on June 9th". false dosePeriodCode A coded value specifying the period during which the dose total is administered. course daily The dose total is defined in periodProductDoseTotal and/or periodActiveIngredientDoseTotal. true endRelativeToReferenceCode A coded value specifying when this event ended with respect to the sponsor-defined reference period. after before during during/after Derived from comparing PerformedSubstanceAdministration.dateRange(IVL<TS.DATETIME>).high and PerformedStudySubjectMilestone.studyReferenceDateRange. Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected. false flowRate A ratio specifying the speed with which the substance is introduced into the subject. 1 g/d 100 mL/h 40 mmol/h false interruptionDuration The period of time during which a substance administration is interrupted. An infusion started at 12:15pm and ended at 2:37pm but there was an interruption of 17 minutes. true periodActiveIngredientDoseTotal The total amount of active ingredient in all doses of treatment in a given period of time. The given period of time is defined in dosePeriodCode. Derived by multiplying PerformedSubstanceAdministration.periodProductDoseTotal (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "true"). false periodProductDoseTotal The total of all doses of treatment in a given period of time. The given period of time is defined in dosePeriodCode. This attribute, periodProductDoseTotal, is not necessarily derivable since the dose may be provided as a string (in productDoseDescription). false plannedChangeIndicator Specifies whether a change in the substance administration in relation to the previous substance administration is planned or not. False = unplanned True = planned false productDose The quantity of a substance or medication used in a substance administration. 5 mg DefinedSubstanceAdministration.productDose can contain a dose expressed in absolute or relative terms (e.g., mg or mg/kg). ScheduledSubstanceAdministration.activeIngredientDose and PerformedSubstanceAdministration.productDose must contain a dose expressed in absolute terms (e.g., mg). If the DefinedSubstanceAdministration.productDose was expressed in relative terms (e.g., mg/kg), then the absolute dose must have been calculated using one or more observed factors as identified by the DefinedExpressionVariableRelationship. false productDoseDescription The textual representation of dosing amounts or a range of dosing information used in a substance administration. 200-400 This is used for more complex dosages such as scaling and tapering doses, uncertain dosage ranges, differing morning and evening doses and other instructions that can't be expressed with a simple PQ. false routeOfAdministrationCode A coded value specifying the physiological path or method of introducing the substance into or onto the subject. chew intravenous oral oral dissolve oral inhalation oral rinse oral topical application swallow Route is more than just approach site. It deals with how the body will actually absorb/receive the drug. The approach site might be "mouth", but from a route code perspective, this could include: swallow, oral rinse, oral topical application, chew, oral dissolve, oral inhalation (via intermittent flow or rebreather mask). The effect of the drug could vary depending on the route even if the body site happens to be the same. false standardTimeIndicator Specifies whether the time of the substance administration is specified using standard (as opposed to daylight savings) time. If the location and date are known, this data is derivable. true startRelativeToReferenceCode A coded value specifying when this event started with respect to the sponsor-defined reference period. Before Medications that are ongoing at the end of the reference period should have a value of "during/after" for this variable. after during during/after Derived from comparing PerformedSubstanceAdministration.dateRange(IVL<TS.DATETIME).low and PerformedStudySubjectMilestone.studyReferenceDateRange. Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected. false substanceUnknownIndicator Specifies whether the substance administered was not known. true treatmentVehicleQuantity The quantity and units of treatment vehicle used. 10 milligrams 2 milliliters Derived by multiplying the PerformedSubstancedAdministration.productDose (the composite product that was administered) with the ProductRelationship.quantity (a ratio) for the component product that is the active ingredient (where ProductRelationship.activeIngredientIndicator = "false"). bridg:PerformedSubstanceExtraction Only Biologic with actualIndicator = "true" is valid. false PerformedSubstanceExtraction The completed action of extracting something from an associated study subject for the purpose of the extracted product to be administered to a study subject. A donor giving Bone Marrow Stem Cells for a Stem Cell Transplant The study subject could be the same for the extraction and the intended administration. This is different than a PerformedSpecimenCollection, in that the intent is different: This is a donation. Only Biologic with actualIndicator = "true" is valid. produces actualIndicator Qualifier bridg:Performer A Performer might be a function performed by one and only one of the following: Person, Organization, Device. false Performer A person, organization or device that participates in an activity. monitoring device performing laboratory surgeon A Performer might be a function performed by one and only one of the following: Person, Organization, Device. be a function performed by Exclusive Or false effectiveDateRange The date (and time) span for when the performer is active. false identifier A unique symbol that establishes identity of the performer. none false performedActivity performs none false performingDevice be a function performed by none false performingOrganization be a function performed by none false performingPerson be a function performed by false postalAddress A contact point used to send physical forms of communication to the performer. false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the performer. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. false typeCode A coded value specifying the kind of performer. monitoring device performing laboratory surgeon bridg:PerformingLaboratory false PerformingLaboratory The laboratory that actually performed the test and that is also therefore the source of the data. A laboratory providing analyses of samples collected in clinical care or research. none false performingLaboratory is a function performed by bridg:Person name, birthDate, deathDate, initials, postalAddress, telecomAddress are valid only when actualIndicator = "true". false Person A human being. name, birthDate, deathDate, initials, postalAddress, telecomAddress are valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false educationLevelCode A coded value specifying the highest level of education completed. High School Diploma Less than High School Diploma Some College false ethnicGroupCode A coded value specifying the self-declared ethnic origination, independent of racial origination. Office of Management and Budget (OMB) approved categories [example from National Cancer Insitute] false initials The first letters of the person's first name, middle name, and last name. If the person does not have a middle name or initial, the initials will only be two characters. false maritalStatusCode A coded value specifying the domestic partnership status of a person. Married Separated Single Widowed false occupationDateRange The date (and time) span specifying the start and end of a person's occupation. The occupation is determined by the Person.primaryOccupationCode. false postalAddress A contact point used to send physical forms of communication to the person. false primaryOccupationCode A coded value specifying the principal activity that a person does to earn money. false raceCode A coded value specifying a self-declared racial origination, independent of ethnic origination. Office of Management and Budget (OMB) approved categories [example from National Cancer Insitute] false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the person. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. bridg:Place physicalAddress should not contain PO Box address parts. false Place A bounded physical location which may contain structures. ambulance emergency department helicopter home manufacturing site patient room service delivery location surgical suite Constraints: Place may be natural or man-made. The geographic position of a place may or may not be constant. Discussion: Places may be work facilities (where relevant acts occur), homes (where people live) or offices (where people work). Places may contain sub-places (floor, room, booth, bed). Places may also be sites that are investigated in the context of health care, social work, public health administration (e.g., buildings, picnic grounds, day care centers, prisons, counties, states, and other focuses of epidemiological events). physicalAddress should not contain PO Box address parts. physicalAddress Qualifier none false containingPlace be contained in false identifier A unique symbol that establishes identity of the place. The license plate number of an ambulance an identifier for a bed in a hospital ward false identifierCode jurisdiction territory code A coded value uniquely specifying the place. European Union (EU) United States (US) The only current use case for this attribute is to specify the geographical area an authority has to make laws and enforce them. For example, the Food and Drug Administration (FDA) exercises responsibility for pharmacovigilance (RegulatoryAuthority.jurisdictionAuthorityCode) in the United States (Place.identifierCode). none false locatedRegulatoryAuthority be the location for false name A non-unique textual identifier for the place "European Union" might be the name of the territory comprised by the EU member states. false physicalAddress A representation of the location of the place. The physicalAddress attribute is meant to provide sufficient information to allow someone to visit a place; it is not intended to provide geographic categorization, a postal address, or a simple name by which a country/state/city is referenced (for a simple name use Place.name). false typeCode A coded value specifying the kind of place. emergency department patient room surgical suite bridg:PlannedActivity A PlannedActivity may have a value for one and only one of the following: repeatDuration or repeatQuantity. A PlannedActivity may have a value for one and only one of the following: repeatFrequencyCode or repeatFrequencyRatio. Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = "false" are valid. false PlannedActivity An activity that is intended to occur or start at some point in the context of a particular study. Pregnancy tests are planned for study subjects who are females of childbearing potential. A PlannedActivity may be a container of other activities and have a complex structure involving components, options and contingencies using the associated relationship classes. This structure allows the representation of concepts in previous versions of BRIDG such as StudyCells, StudySegments and StudySubjectEncounters. A PlannedActivity could also be thought of as an activity at a particular stage in the business process in which the activities occur, i.e., in the "planned" stage rather than the "scheduled" stage or the "performed" stage. An instance of a PlannedActivity is not assigned to a particular Subject, StudySubject, or ExperimentalUnit, but to a "kind of" Subject, StudySubject, or ExperimentalUnit. A PlannedActivity may have a value for one and only one of the following: repeatDuration or repeatQuantity. Repeat Duration or Quantity Exclusive Or A PlannedActivity may have a value for one and only one of the following: repeatFrequencyCode or repeatFrequencyRatio. Repeat Frequency Exclusive Or Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = "false" are valid. be participated in by actualIndicator Qualifier false agentAdministrationCareSettingTypeCode A coded value specifying the level of healthcare (care setting) required by the subject based on the nature of the procedure. All agents given as inpatient All agents given as outpatient Some agents given as inpatient but not all false blindedDescription The textual representation of the planned activity from the point of view of a blinded participant (study subject or study investigator). 5 months Arm 1: standard vaccine given in three shots at 2 months Arm A and B must have identical blindedDescriptions. Arms A and B are still blinded and Arm C is no longer blinded. So During the second treatment epoch of a study In a study with 3 arms and 12 months of age; Arm 2: new vaccine given in three shots at 2 months and 12 months of age; Arm 3: new vaccine given in two shots at 2 months and 5 months of age. Subjects assigned to the third arm are unblinded at some point during 5 months and 12 months. By the time of the Third Shot Epoch its unblinded name. However the "Arm 1/Third Shot" and "Arm2/Third Shot" activities still need blinded names. Both these activities would have the blinded name (something like) "3-shot Arm/Third Shot". the "Arm 3/Third Shot" activity can be called by this none false containingEpoch occur in false description The textual representation of the planned activity. In a migraine study the Wait activity may have a description of "Wait until first grade 2 or 3 migraine". false duration The intended period of time for the planned activity as defined by the study. 6 weeks may be the planned duration for a composite activity that represents the activities occurring during an epoch on arm A. false interruptibleIndicator Specifies whether the planned activity is interruptable by asynchronous events. This may only be useful for PlannedSubjectActivityGroups or administrative activities. false name A non-unique textual identifier for the planned activity. false purpose The reason for the planned activity. determining eligibility for a study (screening) treating a disease (treatment) Per GForge Tracker item 31402, this attribute is redundant and we're deprecating it in favor of the existing Activity.reasonCode. true repeatDuration The period of time over which the planned activity is repeated. Derived from repeatQuantity and repeatFrequencyCode or repeatFrequencyRatio (constraint allows only one). In any given implementation, if quantity is not provided, duration may be provided instead, however the BRIDG team determined that quantity is considered more fundamental for a domain analysis model. false repeatFrequencyCode A coded value specifying the number of occurrences of a planned activity within a given time period. BID = Two times per day Q12H = Every twelve hours at unspecified times (does not necessarily imply that these are 12 hours apart) false repeatFrequencyRatio A ratio representing the number of occurrences of a planned activity within a given time period. 2 times per day Once per 12 hours false repeatQuantityRange An integer falling within minimum and maximum bounds that specifies how many times the planned activity occurs. If the frequency is more than once a day, this is still interpreted per time, e.g. BID for 5 days is 10 repeats. true studyDayRange Visit Day The relative timing for a planned activity expressed as the number of days offset from the study-defined reference activity (e.g., date of registration, start of treatment) for a particular subject, study subject or experimental unit. Day 1 Days 10-20 Derived from all the pauseQuantity values of the composite activity structures that this activity is a part of minus the offset of the reference activity. The study-defined reference activity can be different from study to study. The study day for a date after this reference activity is a positive integer calculated as the difference in the two dates + 1. The study day for dates before the reference activity is a negative integer calculated as the difference between the two dates. Note that this means there is no "Day 0." none false usedStudyActivity is a use of bridg:PlannedCompositionRelationship false PlannedCompositionRelationship A relationship between a composite activity and a component activity that comprises it, i.e. parent and child activities where all activities are intended to occur at some point in the context of a particular study. A battery of tests may be composed of multiple routine labs that are always ordered together as a group. A glucose tolerance test which is comprised of administering glucose and taking multiple timed blood samples which are then tested for glucose. This class helps represent an AND relationship between siblings with the same parent activity. none false componentPlannedActivity is the parent of none false compositePlannedActivity is the component of false joinCode A coded value specifying whether, and how, a specific activity in a set of parallel activities should come together before subsequent activities can begin. Wait for this activity to complete before the subsequent activity; Terminate this activity as soon as all parallel "wait" activities are completed (and if this activity hasn't started yet but don't wait for it to complete before beginning subsequent activities. don't start it at all); Continue this activity after all "wait" activities complete false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false sequenceNumber An integer specifying the relative sequential or temporal ordering of this relationship among other similar relationships having the same source. In a course of treatment (a composite activity) that is composed of a chemotherapy activity and a radiotherapy activity, the sequence number indicates which component activity precedes the other. bridg:PlannedContingentOnRelationship A PlannedContingentOnRelationship must be associated to one and only one of the following: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. completionRequiredBeforeStartingIndicator may only be used if the target of this relationship is an activity, not if the target is an observation result or a criterion group. false PlannedContingentOnRelationship A relationship between a planned activity and some criteria to determine if the activity should occur where all activities are intended to occur at some point in the context of a particular study. Only perform a certain lab test if drug X was administered. (target = another activity) Only perform a substance administration of drug X if the blood pressure was over some threshold number. (target = observation result from another activity that is an observation) Only perform a substance administration of drug Y if the blood pressure was over some threshold number and either the result of a certain lab test was positive or the subject's temperature was elevated i.e. "(A and (B or C))". The criteria may be one of the following: - another planned activity where the source activity does not occur unless the target activity has occurred - the defined outcome of another planned activity where the source activity does not occur unless the target activity outcome has occurred - a planned group of other criteria that may be composed of a mix of other activities, observation results and/or other groups To evaluate whether the contingency was satisfied, the simple existence of a PerformedActivity (or subclass) related to the DefinedActivity (or subclass) is not enough by itself. The PerformedActivity.statusCode and PerformedActivity.negationIndicator must also be checked to ensure that the activity was actually performed. PerformedActivity.statusCode must be "Completed" and PerformedActivity.negationIndicator must not be "true". A PlannedContingentOnRelationship must be associated to one and only one of the following: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. be contingent upon Exclusive Or completionRequiredBeforeStartingIndicator may only be used if the target of this relationship is an activity, not if the target is an observation result or a criterion group. completionRequiredIndicator Qualifier false checkpointCode The checkpointCode specifies when the precondition is to be checked; it is analogous to the various conditional statements and loop constructs in programming languages "while-do" vs. "do-while" or "repeat-until" vs. "loop-exit." false completionRequiredBeforeStartingIndicator Specifies whether the target activity must have completed prior to starting the source activity. This attribute may only be used if the target is an activity, not if the target is an observation result or a criterion group. none false contingentPlannedActivity is a condition for false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. For the more complex examples of doing activity A 5 minutes after the start of B or 5 minutes after the end of B Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. use pauseQuantity in combination with completionRequiredBeforeStartingIndicator where the pauseQuantity in both cases would be 5 minutes and "after the start of" would be completionRequiredBeforeStartingIndicator = "false" and "after the end of" = "true". The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. none false prerequisiteDefinedObservationResult be contingent upon none false prerequisitePlannedActivity be contingent upon none false prerequisitePlannedCriterionGroup be contingent upon false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. bridg:PlannedCriterionGroup false PlannedCriterionGroup A collection of conditions joined together via composition (ANDed) and/or optionality (ORed) to form a logical expression upon which the execution of an activity is based or upon which the cessation of a repeated activity is based, where components of the group may include other activities, observation results and/or other criterion groups, and where both the criterion group and its components are planned to be used at a particular point in a particular study. (A and (B or C)) B and C might be 2 different observation results and the two sets of parentheses are 2 criterion groups one inside (a component of) the other. where A might be an activity A criterion group represents the parentheses around a set of criteria in a logical expression. bridg:PlannedCriterionGroupCompositionRelationship A PlannedCriterionGroupCompositionRelationship must be associated to one and only one of the following targets: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. false PlannedCriterionGroupCompositionRelationship A relationship between a planned criterion group and a planned activity, planned observation result or other planned criterion group that is a component, i.e. a relationship between a logical set of parenthesis and one of the items inside the parentheses. A battery of tests may be composed of multiple routine labs that are always ordered together as a group. A glucose tolerance test which is comprised of administering glucose and taking multiple timed blood samples which are then tested for glucose. This class helps represent an AND relationship between siblings in the same criterion group. A PlannedCriterionGroupCompositionRelationship must be associated to one and only one of the following targets: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. be the parent of Exclusive Or none false componentDefinedObservationResult be the parent of none false componentPlannedActivity be the parent of none false componentPlannedCriterionGroup be the parent of none false compositePlannedCriterionGroup is the component of false joinCode A coded value specifying whether, and how, a specific activity in a set of parallel activities should come together before subsequent activities can begin. Wait for this activity to complete before the subsequent activity; Terminate this activity as soon as all parallel "wait" activities are completed (and if this activity hasn't started yet but don't wait for it to complete before beginning subsequent activities. don't start it at all); Continue this activity after all "wait" activities complete false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false sequenceNumber An integer specifying the relative sequential or temporal ordering of this relationship among other similar relationships having the same source. In a criterion group that is composed of a substance administration activity and a lab test activity the sequence number indicates which activity precedes the other. bridg:PlannedCriterionGroupOptionRelationship A PlannedCriterionGroupOptionRelationship must be associated to one and only one of the following targets: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. false PlannedCriterionGroupOptionRelationship A relationship between a planned criterion group and an option that can satisfy it, either a planned activity, a planned observation result or another planned criterion group, i.e. a relationship between a logical set of parenthesis and one of the options inside the parentheses. A pain management criterion group may be comprised of three options and a third for substance administration of ibuprofen. The pain management criterion would be satisfied/accomplished with any one of these activities and would be associated to each of the three via a different DefinedCriterionGroupOptionRelationship. another for substance administration of aspirin one for substance administration of Tylenol This class helps represent an OR relationship between siblings in the same criterion group. A PlannedCriterionGroupOptionRelationship must be associated to one and only one of the following targets: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. is a choice that has as option Exclusive Or none false choicePlannedCriterionGroup is an option that can satisfy none false optionDefinedObservationResult be a choice that has as option none false optionPlannedActivity be a choice that has as option none false optionPlannedCriterionGroup be a choice that has as option false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. bridg:PlannedEligibilityCriterion true PlannedEligibilityCriterion An activity that is intended to occur at some point in the context of a particular study that represents a characteristic or requirement intended to be applied to a potential study subject to determine whether or not they may participate in a study. The reason for the PlannedEligibilityCriterion structure is to allow questions defined as agnostic criteria in DefinedEligibilityCriterion, that is, they could be used either as inclusion or exclusion criteria, to be referenced in specific study protocols and allow the inclusion/exclusion distinction to be determined for that study specifically. bridg:PlannedExclusionCriterion false PlannedExclusionCriterion An activity that is intended to occur at some point in the context of a particular study that represents a characteristic or requirement intended to be applied to a potential study subject to determine whether they may not participate in a study. The reason for the PlannedEligibilityCriterion structure is to allow questions defined as agnostic criteria in DefinedEligibilityCriterion, that is, they could be used either as inclusion or exclusion criteria, to be referenced in specific study protocols and allow the inclusion/exclusion distinction to be determined for that study specifically. bridg:PlannedInclusionCriterion false PlannedInclusionCriterion An activity that is intended to occur at some point in the context of a particular study that represents a characteristic or requirement intended to be applied to a potential study subject to determine whether they may participate in a study. The reason for the PlannedEligibilityCriterion structure is to allow questions defined as agnostic criteria in DefinedEligibilityCriterion, that is, they could be used either as inclusion or exclusion criteria, to be referenced in specific study protocols and allow the inclusion/exclusion distinction to be determined for that study specifically. bridg:PlannedNotification A PlannedNotification may have a value for one and only one for the following: studyAccrualThresholdPercent or studySiteAccrualThresholdPercent. Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. Only Organization or Person (via NotificationReceiver) with actualIndicator = "false" is valid. false PlannedNotification An activity that is intended to occur at some point in the context of a particular study that represents the communication of a message to a recipient. A PlannedNotification may have a value for one and only one for the following: studyAccrualThresholdPercent or studySiteAccrualThresholdPercent. Accrual Threshold Percent Exclusive Or Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only Organization or Person (via NotificationReceiver) with actualIndicator = "false" is valid. be received by actualIndicator Qualifier false studyAccrualThresholdPercent An integer specifying a percentage of target accrual for a study, which when reached triggers a notification. 75% or 90% of the target accrual number. false studySiteAccrualThresholdPercent An integer specifying a percentage of target accrual at a particular study site, which when reached triggers a notification. 75% or 90% of the target accrual number. bridg:PlannedOptionRelationship false PlannedOptionRelationship A relationship between a composite activity and an option that can satisfy it, i.e. choice and option activities, where all the activities are intended to occur at some point in the context of a particular study. A pain management activity may be comprised of three options and a third for substance administration of ibuprofen. The pain management activity would be satisfied/accomplished with any one of these activities and would be associated to each of the three via a different DefinedOptionRelationship. another for substance administration of aspirin one for substance administration of Tylenol This class helps represent an OR relationship between siblings with the same parent activity. none false choicePlannedActivity is an option that can satisfy none false optionPlannedActivity is a choice that has as option false pauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time between when an activity is ready for execution and the actual beginning of the execution. Take a blood sample 15 minutes after administration of study drug or measure blood glucose 2 hours after each meal the pauseQuantity would be 15 minutes and 2 hours respectively. The pauseQuantity defines the amount of time between two points in time: (1) the point when all preceding steps (in sequence) and preconditions of an activity have been completed, and (2) the actual start of the activity. The completion of all pre-conditions and preceding steps (based on sequence number) indicates that an activity is "ready for execution" according to the definition above. The pauseQuantity counter or timeclock starts then, and when the full amount of time is reached, the activity begins. A pauseQuantity with a negative value means that the activity starts some amount of time prior to the estimated time that the activity is "ready for execution", i.e. prior to the estimated time that the pre-conditions and preceding steps will be completed. false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. bridg:PlannedRandomizationBookAllocation A PlannedRandomizationBookAllocation can only reference a StudyActivity that points to DefinedExperimentalUnitAllocation, not any other DefinedActivity subclass. Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid. The Repeat attributes should not be used for a PlannedRandomizationBookAllocation. false PlannedRandomizationBookAllocation An activity that is intended to occur at some point in the context of a particular study and that is the assignment of an experimental unit to a portion of the study, such as an arm or a portion of an arm (when secondary allocations may occur) based on a randomization book. A randomization book is a predefined set of assignments to portions of a study based on criteria, such as stratum group for example, that ensures a desired distribution of experimental units across those portions of the study. For example, the book entries indicate which arm a given experimental unit, Joe, is assigned to based on the fact that he's the 5th person in stratum group #2. A PlannedRandomizationBookAllocation can only reference a StudyActivity that points to DefinedExperimentalUnitAllocation, not any other DefinedActivity subclass. DefinedActivity Qualifier Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid. be participated in by Qualifier The Repeat attributes should not be used for a PlannedRandomizationBookAllocation. Repeat Not Applicable bridg:PlannedRepeatActivityUntilRule A PlannedRepeatActivityUntilRule must be associated to one and only one of the following: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. false PlannedRepeatActivityUntilRule A relationship between a planned repeating activity and the criteria that may trigger the repeating activity to stop, where all items are intended to occur at some point in the context of a particular study. Continue repeating kidney dialysis until kidney transplant surgery. The criteria may be one of the following: - another planned activity where the repeating activity stops if this other activity occurs - a defined observation result where the repeating activity stops if this observation result occurs as a result of a planned observation - a planned criteria group where the repeating activity stops if this group logically evaluates to true based on its components A PlannedRepeatActivityUntilRule must be associated to one and only one of the following: PlannedActivity, DefinedObservationResult, PlannedCriterionGroup. be repeated until Exclusive Or false cessationPauseQuantityRange A quantity of time falling within minimum and maximum bounds that specifies the elapsed time after the observed result occurs and before the cessation of repeating the activity. Stop 20 days after the observed event occurs. false checkpointCode The checkpointCode specifies when the precondition is to be checked; it is analogous to the various conditional statements and loop constructs in programming languages "while-do" vs. "do-while" or "repeat-until" vs. "loop-exit." false priorityNumber A number specifying the relative preference for considering this relationship before other like-typed relationships having the same source activity. Relationships with lower priorityNumber values are considered before and above those with higher values. The ordering may be a total ordering, in which all priority number are unique, or a partial ordering, in which the same priority may be assigned to more than one relationship. Decimal numbers may be used to insert values between existing priority numbers. For multiple criteria, this specifies which criteria are considered before others. Among alternatives or options that are being chosen by humans, the priorityNumber specifies preference. none false repeatedPlannedActivity triggers the cessation of none false triggeringDefinedObservationResult be repeated until none false triggeringPlannedActivity be repeated until none false triggeringPlannedCriterionGroup be repeated until bridg:PlannedStudySite A PlannedStudySite is a function planned to be performed by one and only one of the following: HealthcareFacility, Organization (serving as a PlannedStudySite but is not a HealthcareFacility). false PlannedStudySite A facility in which study activities are intended to be conducted. The site where the study subject encounter is intended to occur or the site of the Investigator. A PlannedStudySite is a function planned to be performed by one and only one of the following: HealthcareFacility, Organization (serving as a PlannedStudySite but is not a HealthcareFacility). be a function planned to be performed by Exclusive Or false duration The intended period of time for the planned study site's participation in the study. none false executesStudyProtocolVersion plans to execute false leadIndicator Specifies whether this is the principal administrative organization intended to be responsible for the study. Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization. none false performingHealthcareFacility be a function planned to be performed by none false performingOrganization be a function planned to be performed by bridg:PlannedStudySubject Only BiologicEntity, Material (via Subject) with actualIndicator = "false" is valid. false PlannedStudySubject A kind of physical entity which is intended to be the primary unit of operational and/or administrative interest in a study. 10 Adult males 20 female 6-month old chickens Some studies may specify multiple kinds of subjects, each with their own quantity. Only BiologicEntity, Material (via Subject) with actualIndicator = "false" is valid. be a function performed by actualIndicator Qualifier false quantityRange An integer falling within minimum and maximum bounds that specifies how many of a particular type of subject are planned to be included in the study. bridg:PlannedSubjectActivityGroup Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. false PlannedSubjectActivityGroup course cycle period study segment time point treatment strategy visit A collection of activities that are intended to occur or start for the same study subject at a specific point in the context of a particular study. A treatment strategy that consists of drug administrations with rules for modifying doses Clinic visit during which a physical exam Recording multiple observation results in a diary Telephone contact during which temperature a blood test and a substance administration occur blood pressure and adverse events are reported Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid. be participated in by Qualifier true sequenceNumber Visit Number An integer specifying the order of a visit within a study. Derived from the sequence number that orders this activity group within a larger activity group: PlannedSubjectActivityGroup [visit, timepoint or other kind of group] > PlannedCompositionRelationship.sequenceNumber > PlannedSubjectActivityGroup [set of planned visits for the study or some other larger activity group] false targetAccrualNumberRange An integer falling within minimum and maximum bounds that specifies how many subjects are to be accrued for the planned subject activity group. bridg:PrincipalStatisticalAnalysisPlanVersion false PrincipalStatisticalAnalysisPlanVersion A type of statistical analysis plan that is the main, comprehensive, pre-specified collection of analyses that support the Clinical Study Report (CSR) or other similar study report. Analyses that arise after PrincipalStatisticalAnalysisPlanVersion finalization but during preparation of the clinical study report are handled by SupplementalStatisticalAnalysisPlanVersion. bridg:ProcessedProduct false ProcessedProduct Specifies the link between a processor and a product produced by that processor. false identifier A unique symbol used by the processor to establish identify of a particular product type or line. catalog number There are multiple ways in which an identifier can be associated to a product; inherited from MaterialIdentifier.identifier, the association to ProcessedProduct.identifier, and the association to ProductRelationship.identifier. If there is no context associated with the identifier, then MaterialIdentifier.identifier should be used. However, if the identifier for a product would be different in a different context, one of the other identifiers should be used. If a kind of product is produced by different processors, and each processor assigns the product a different identifier, then ProcessedProduct.identifier should be used. If the product is used in multiple assemblies, and in each assembly it would be assigned a different identifier, then ProductRelationship.identifier should be used. none false producedProduct produces none false producingProcessor is produced by bridg:ProcessingSite false ProcessingSite The particular plant or processing location at which the product was processed GSK Zebulon NC The site could pertain to a different corporation than the one which is the formal manufacturer. bridg:Processor false Processor An organization defined as being responsible for making, assembling, refurbishing, packaging, etc. a product. The maker identified on the product's box. In some cases, the responsible organization will actually be listed as a reprocessor of the item. none false performingOrganization is a function performed by bridg:Product If Product.actualIndicator = "true", then the upper limit is 1 on the Distributor association. If Product.actualIndicator = "true", then the upper limit is 1 on the ProcessingSite association. If Product.actualIndicator = "true", then the upper limit is 1 on the Processor association. effectiveDateRange, codeModifiedText, lotNumberText, expirationDate are valid only when actualIndicator = "true". false Product A thing produced by or resulting from a process. animal and human drugs; therapeutic biologics; allergenics; cell device drug tissue and gene therapy products; blood components; blood derivative products; devices; animal (pets and livestock) and human food/feed (medicated and un-medicated); cosmetics; pet treats; dietary supplements [examples from FDA's list of regulated products] If Product.actualIndicator = "true", then the upper limit is 1 on the Distributor association. Distributor Qualifier If Product.actualIndicator = "true", then the upper limit is 1 on the ProcessingSite association. ProcessingSite Qualifier If Product.actualIndicator = "true", then the upper limit is 1 on the Processor association. Processor Qualifier effectiveDateRange, codeModifiedText, lotNumberText, expirationDate are valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false classCode A coded value specifying a group of products that are homogeneous or generally considered as substitutes for each other. breakfast cereals cox-2 inhibitors stents The class is considered as narrow or broad depending on how substitutable the various products are. false codeModifiedText A character string that is a revision of the original text of the product to enable the coding of the text. If the original text is "aspriin" so that the text can be successfully coded. the CodeModifiedText could be set to "aspirin" In the context of BRIDG, text modification occurs a single time for a given instance of originalText. false expirationDate The date (and time), assigned by the manufacturer, on which the product should not be used. false lotNumberText An alphanumeric string used to identify a particular batch of the product. false pre1938Indicator Specifies whether the product qualifies under the 1938 Grandfather Clause, contained in section 20l(p)(l) of the U.S. Federal Food, Drug and Cosmetic Act. false typeCode A coded value specifying the kind of product. diagnostic device veterinary medicine All members of a type share similar functions and general characteristics, especially the purpose for which they are used. bridg:ProductGroup identifier is valid only when actualIndicator = "true". false ProductGroup A collection of instances of a product. 10 pills 5 pace makers identifier is valid only when actualIndicator = "true". Attribute Set actualIndicator Qualifier false actualIndicator Specifies whether the product group is a particular instance (actual) vs. universal kind. To indicate a particular ProductGroup actualIndicator = "false". actualIndicator = "true". To indicate a kind of ProductGroup false identifier A unique symbol that establishes identity of the product group. false quantity The number of members in a product group. 10 pills 5 pace makers bridg:ProductRelationship identifier is only valid when Product.actualIndicator = "false". false ProductRelationship Specifies the link between one product and another. assembly content equivalent ingredient kind lot package part specialized identifier is only valid when Product.actualIndicator = "false". identifier Qualifier false activeIngredientIndicator Specifies whether the ingredient is an active ingredient. false confidentialityCode A coded value specifying the privacy requirements for information about this relationship. A manufacturer considers an ingredient in a product to be a trade secret. false effectiveDateRange The date (and time) span for when the product relationship is active. false identifier A unique symbol that establishes identity of the product within the context of another product. There are multiple ways in which an identifier can be associated to a product; inherited from MaterialIdentifier.identifier, the association to ProcessedProduct.identifier, and the association to ProductRelationship.identifier. If there is no context associated with the identifier, then MaterialIdentifier.identifier should be used. However, if the identifier for a product would be different in different context, one of the other identifiers should be used. If a kind of product is produced by different processors, and each processor assigns the product a different identifier, then ProcessedProduct.identifier should be used. If the product is used in multiple assemblies, and in each assembly it would be assigned a different identifier, then ProductRelationship.identifier should be used. false quantity An indication of the amount of one product contained in another product. 300 ml / liter 50 mg per tablet none false sourceProduct has as source none false targetProduct has as target false typeCode A coded value specifying the kind of relationship a product has with another product. assembly content equivalent ingredient kind lot package part specialized bridg:QualifiedPerson At least one of the following attributes must be mandatory for a QualifiedPerson: typeCode, certificateLicenseText. false QualifiedPerson A person that has been recognized as having certain training/experience or other characteristics that would make that person an appropriate performer for a certain activity. academic degree board certification medical license At least one of the following attributes must be mandatory for a QualifiedPerson: typeCode, certificateLicenseText. Mandatory Attribute Qualifier false certificateLicenseText A character string that describes the specific credentials of the qualified person. Certification from the American Board of Pediatrics MD from the John Hopkins University School of Medicine Medical license from the state of Maryland none false credentialingOrganization is credentialed by false effectiveDateRange The date (and time) span for when the qualification of this person is active. false identifier A unique symbol that establishes identity of the qualified person. The identifier assigned in the NCI investigator registry (National Cancer Institute Principal Investigator Identifier Number) to a physician approved for conducting a clinical study. none false locatingPlace be qualified in none false performingPerson is a function performed by false typeCode A coded value specifying the kind of qualification a person has. academic degree license bridg:RandomizationBookEntry false RandomizationBookEntry An item/element of a randomization book that can be used to assign an experimental unit to a planned arm or portion of an arm in a study. An entry might be mapping the 5th experimental unit in a given Stratum Group to a particular treatment Arm. A randomization book is a predefined set of assignments to portions of a study based on criteria, such as stratum group for example, that ensures a desired distribution of experimental units across those portions of the study. For example, the book entries indicate which arm a given experimental unit, Joe, is assigned to based on the fact that he's the 5th experimental unit in stratum group #2. none false definingPlannedRandomizationBookAllocation is defined by false positionFilledIndicator Specifies whether the position is filled by an experimental unit assignment. false positionNumber An integer specifying the value of a numerical sequence for a stratum group that should be used to assign an experimental unit to an arm or a portion of an arm. If 2 experimental units fall in the same Stratum Group i.e. say 0 in the above example StratumGroup#: 0; Position: 0; Arm/Portion of Arm: A StratumGroup#: 0; Position: 1; Arm/Portion of Arm: B the first will be assigned Arm A because the current position would be 0 and the 2nd would be assigned Arm B since the current position would be incremented by 1 each time an assignment happens. none false randomizedStratumGroup randomize bridg:ReferenceResult Only Device or Organization (via PerformingLaboratory) with actualIndicator = "true" is valid. false ReferenceResult Normal range alert range clinical concern range data checking range limit of quantitation reference range The possible or expected results that can be obtained by observing, monitoring, measuring or otherwise qualitatively or quantitatively recording one or more aspects of physiologic or psychologic processes. ReferenceResult > PerformingLaboratory > Laboratory > Organization.name = Acme Labs ReferenceResult.fastingStatusIndicator = true ReferenceResult.populationScopeCode = adult ReferenceResult.populationScopeCode = adult females ReferenceResult.populationScopeCode = adult males ReferenceResult.referenceTypeCode = limit of quantitation ReferenceResult.referenceTypeCode = normal range ReferenceResult.value(ANY=>IVL<PQ>) = 110-130 mm[Hg] ReferenceResult.value(ANY=>IVL<PQ>) = 12.1 to 15.1 g/dL ReferenceResult.value(ANY=>IVL<PQ>) = 2-60 nanograms/ml ReferenceResult.value(ANY=>IVL<PQ>)= 3.6 to 5.8 mmol/L ReferenceResult.valueTypeCode = PK assay ReferenceResult.valueTypeCode = blood glucose measurement ReferenceResult.valueTypeCode = hemoglobin concentration measurement ReferenceResult.valueTypeCode = systolic blood pressure The limit of quantitation for a PK assay The normal range for a fasting blood glucose measurement on an adult performed by Acme Labs is 3.6 to 5.8 mmol/L: The normal range for a hemoglobin concentration measurement on an adult female performed by Acme Labs is 12.1 to 15.1 g/dL: The normal range for a systolic blood pressure reading is 110-130 for adult males: concentration of drug XYZ concentration of drug XYZ is 2-60 nanograms/ml for adult women as processed by Acme Labs: The context of a reference result may include any combination of the following: the performing lab, the performing device, and the population to which the reference value pertains. The context may also omit any of those aspects as well. Only Device or Organization (via PerformingLaboratory) with actualIndicator = "true" is valid. apply to results produced by actualIndicator Qualifier false comment Additional description of the reference result. false fastingStatusIndicator Specifies whether the result applies to when the subject had abstained from eating when the specimen is obtained. none false performingDevice apply to results produced by none false performingPerformingLaboratory apply to results produced by false populationScopeCode A coded value specifying the type of subjects to which this reference result applies. adult females adult males minor females minor males false referenceTypeCode A coded value specifying the kind of reference, i.e. how it is to be used or what its purpose is. alert range clinical concern range data checking range limit of quantitation normal range false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of a reference result. Arm for skin rash Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false targetAnatomicSiteLateralityCode A coded value specifying the side of the body (or a paired organ) that is a target site for a result. bilateral left right This attribute is deprecated in BRIDG 3.1 since the only source use case for splitting out laterality from anatomic site comes from CTOM. All other source models had these concepts combined in one attribute. Therefore it was determined to combine these attributes to match the majority of use cases. false value A reference for some measurement that a physician or other health professional can use to interpret a set of results for a particular experimental unit. For systolic blood pressure ReferenceResult.value(ANY) would be constrained to IVL<PQ> and would = 110-130 mm[Hg] false valueTypeCode A coded value specifying the kind of clinical result to which this reference result must be associated. For a blood pressure measurement the valueTypeCode may be systolic or diastolic. bridg:ReferenceToStudyResults false ReferenceToStudyResults A citation in an external publication that refers to results of this study. CT.gov instruction say to provide either the unique PubMed Identifier (PMID) of an article or enter the full bibliographic citation. "Inbound" references, could be to interim or final results, not a reference from this study to other studies. false citationDescription A biblographical reference in a format acceptable to the registration authority. Studies performed in the United States may be required to conform to the National Library of Medicine's MEDLINE format. false linkPageDescription The textual representation of the linked page. If the page being linked is the protocol's home page on the sponsor's Web site include the words "Click here for more information about this study:" and provide the name of the protocol. false publicationIdentifier A unique symbol that establishes identity to a publication that cites this study's results. 10987815 is the unique PubMed Identifier (PMID) for the citation in MEDLINE. false publicationName A non-unique textual identifier specifying the source of the publication identifier. MEDLINE is the source for PMID 10987815 none false referencedStudyExecution references the results of false uniformResourceLocator A complete reference to a website (including http://) that is directly relevant to the study. http://www.alzheimers.org/ bridg:RegistrationCenter false RegistrationCenter The service of recording subject participation on a study. The service may include allocation to an Arm or a portion of an Arm (when secondary allocations may occur). false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of a registration center. The phone number to call to request that a subject be registered and randomized on a study. bridg:RegulatoryApplication false RegulatoryApplication A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance. The marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions each with their own regulatory action. Over time, an application will typically consist of multiple submissions and regulatory assessments. false identifier A unique symbol that establishes identity of the regulatory application. false typeCode A coded value specifying the kind of regulatory application. 510k New Drug Application Veterinary New Drug Submission Each product type will be supported by a different application type. bridg:RegulatoryApplicationSponsor A RegulatoryApplicationSponsor might be a function performed by one and only one of the following: Organization, HealthcareProvider. Only Organization with actualIndicator = "true" is valid. false RegulatoryApplicationSponsor An organization or person that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the continuation of marketing of new drugs or devices. pharmaceutical company A RegulatoryApplicationSponsor might be a function performed by one and only one of the following: Organization, HealthcareProvider. be a function performed by Exclusive Or Only Organization with actualIndicator = "true" is valid. be a function performed by actualIndicator Qualifier false effectiveDateRange The date and time span for when the regulatory application sponsor is active. none false performingHealthcareProvider be a function performed by none false performingOrganization be a function performed by bridg:RegulatoryAssessment Only Organization (via OversightAuthority) with actualIndicator = "true" is valid. false RegulatoryAssessment An evaluation of a submission by a regulatory body. The FDA evaluates a submission for a new drug or device. Only Organization (via OversightAuthority) with actualIndicator = "true" is valid. is a function performed by actualIndicator Qualifier false completionDate The date (and time) on which this particular assessment is completed. false expectedResubmissionDate The date on which the resubmission of the regulatory application is expected. Used only when RegulatoryAssessment.statusCode is not complete. Regulatory authorities typically assign a resubmission deadline such as 30 days. false identifier A unique symbol that establishes identity of the regulatory assessment. 510K Biologic License Application (BLA) Investigational New Drug (IND) number New Drug Application (NDA) number Premarket Approval (PMA) none false performingRegulatoryAuthority is performed by false reasonCode A coded value specifying the rationale for a regulatory designation. false resultCode A coded value specifying the regulatory designation made by the regulatory authority. For expanded access submissions the code can be: Available For regular submissions the code can be: approved No longer available Temporarily not available approvable complete response or cleared. not approvable or Approved for marketing. For some submissions, there are business processes that will make "default" action based on timelines --i.e., if no action is taken, then the submission is "approved". For a submission, there may be multiple regulatory assessments that correspond to the state transitions for a submission, but only one regulatory assessment is true at a given time. A submission can first be "approvable" and then when the data is complete, a new regulatory assessment can be made that is "approved". false statusCode A coded value specifying the phase in the lifecycle of the assessment. complete pending false typeCode A coded value specifying the approval process used by the regulatory authority. FDA's Center for Devices and Radiological Health (CDRH) Process FDA's Center for Drug Evaluation and Research (CDER) Process bridg:RegulatoryAuthority false RegulatoryAuthority Governmental bodies that have the power to pass and enforce laws. Food and Drug Administration (FDA) in the USA Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK false effectiveDateRange The date and time span for when the regulatory authority is active. false jurisdictionAuthorityCode A coded value specifying the type of governance over which an authority has to make laws and enforce them. The Food and Drug Administration (FDA) exercises responsibility for pharmacovigilance (jurisdictionAuthorityCode) in the United States (Place.identifierCode). bridg:RelevantRegulation false RelevantRegulation Specifies the jurisdictional law that may be applicable for registering the study to a clinical trial registry. false applicableIndicator Section 801 Clinical Trial Specifies whether this study must be registered as required by applicable laws. Under US Public Law 110-85, Title VIII, Section 801, applicable drug trials include controlled clinical investigations, other than Phase I investigations, of a drug or biologic subject to US FDA regulation. Applicable device clinical trials are controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric postmarket surveillance. false code A coded value specifying a regulation that requires the study to be registered. 510(k) 515 520(m) Drug and Cosmetic Act: 505 US Food and Drug Administration regulation under section 351 of the Public Health Service Act or any of the following sections of the Federal Food and 522. bridg:ReportReceiver A ReportReceiver might be a function performed by one and only one of the following: Person, Organization. false ReportReceiver A role of a person or an organization that receives or is intended to receive a report.. A ReportReceiver might be a function performed by one and only one of the following: Person, Organization. be a function performed by Exclusive Or none false performingOrganization be a function performed by none false performingPerson be a function performed by false receivedDate The date (and time) on which the report was received. false receivedIndicator Specifies whether the receiver received the report. none false receivedReportVersion receives bridg:ReportSubmitter false ReportSubmitter A role of a person who submits a report. none false performingResearchStaff is a function performed by none false submittedSafetyReportVersion submits bridg:ReportVersion false ReportVersion A document characterized by information or other content which is tailored to the context of a given situation and audience. Safety Report Study Report false communicationModeCode A coded value specifying the form in which the report is transmitted. electronic over the telephone physically present written communication none false describedPerformedObservationResult describe false dueDate The date (and time) on which the report is expected or scheduled to be submitted. false physicianSignOffIndicator Specifies whether the physician has reviewed and signed off on a version of a report. Theoretically speaking, the physicianSignoffIndicator could be derived from the existence of an authenticating person for the report. However, authenticating person is not represented in the BRIDG model because this use case has not yet been formally presented to BRIDG. If and when this use case is presented to BRIDG the physicianSignoffIndicator will be marked as derived, but for now this attribute will remain as not derivable. bridg:Reprocessor false Reprocessor An organization that is typically in the business of re-using or refurbishing a product (such as a medical device) so that it can be used again. These kind of organizations must comply with the same requirements that apply to original equipment manufacturers. These organizations are typically referred to as third part or hospital reprocessors. Reprocessing of medical devices is done to save costs and reduce wastes. bridg:ResearchOrganization false ResearchOrganization An organization whose purpose is to support systemic, rigorous study and investigation into a particular field or fields. Clinical Research Organization (CRO) false effectiveDateRange The date (and time) span for when the research organization is active. none false performingOrganization is a function performed by false typeCode A coded value specifying the kind of research organization. cancer center clinical center drug company institute bridg:ResearchStaff Each Person can have more than one ResearchStaff role but each of them must be for a different ResearchOrganization (no duplicate Person/ResearchOrganization pairs). false ResearchStaff Individual who is employed and/or involved in any aspect of conduct of protocol driven research. administrators clinical and data managers clinical research associates clinical research pharmacists clinical trials compliance coordinators clinical trials specialists laboratory technologists nurses research services consultants study coordinators and others Each Person can have more than one ResearchStaff role but each of them must be for a different ResearchOrganization (no duplicate Person/ResearchOrganization pairs). Person-ResearchOrganization Pair Unique false effectiveDateRange The date (and time) span for when the research staff is active. false identifier A unique symbol that establishes identity of the research staff. false jobTitle A local name for the research staff's occupation. none false performingPerson is a function performed by false postalAddress A contact point used to send physical forms of communication to the research staff. none false staffedResearchOrganization staffs false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the research staff. NOTE(S): The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. bridg:Resource false Resource Items necessary to support a research study. Funding labor material false activeIndicator Specifies whether the resource is active. none false providingResourceProvider be provided by bridg:ResourceProvider A ResourceProvider might be a function performed by one and only one of the following: Organization, Person. false ResourceProvider An organization or person that provides financial or other resources for the conduct of research. National Cancer Institute National Institutes of Health [Federal Agency examples] Pharmaceutical companies [private industry example] A ResourceProvider might be a function performed by one and only one of the following: Organization, Person. be a function performed by Exclusive Or false effectiveDateRange The date (and time) span for when the resource provider is active. false identifier A unique symbol that establishes identity of the resource provider. none false performingOrganization be a function performed by none false performingPerson be a function performed by bridg:ReviewableUnit false ReviewableUnit A discrete portion of a submission which is used to receive agreement. Once agreement is reached on all units within the submission the submission can then be approved. A veterinary medicine New Animal Drug Application (NADA) (marketing application) is constructed from the Investigational New Animal Drug Application (INADA). In the INADA process the sponsor creates reviewable units. These reviewable units are then compiled to be used as documentation for the marketing application. In a Modular pre-marketing application (PMA) several modules will be sent to the Food and Drug Administration (FDA). Each module will be agreed upon independently of other modules. The FDA then approves the submission based on compilation of all of the modules. These modules are reviewable units. none false groupingSubmission is grouped into false typeCode A coded value specifying the kind of reviewable unit. administrative manufacturing safety toxicology bridg:SafetyReportVersion A SafetyReportVersion describes one and only one of the following: AdverseEvent, PerformedProductProblemDiscovery. false SafetyReportVersion A report that provides notification of an adverse event, product problem, and/or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender/receiver organizations, subject or study subject of adverse event, or name of product. An Expedited AE report - a report of a serious and unexpected adverse event that must be submitted within specific timeframes to the sponsor and regulatory agencies. A SafetyReportVersion describes one and only one of the following: AdverseEvent, PerformedProductProblemDiscovery. describes Exclusive Or none false describedAdverseEvent describe none false describedPerformedProductProblemDiscovery describe false nullificationIndicator Specifies whether the report cancels a previously sent adverse event. false nullificationReasonCode A coded value specifying why the adverse event report is nullified. false subtypeCode A coded value specifying a further classification of type. An Adverse Event Report would map to Document.typeCode and the SafetyReportVersion.subtypeCode would map to a 7-day AE Report. bridg:SampleSizeConsideration false SampleSizeConsideration Information needed for computing the sample size, including any detail not provided in the study protocol. "Approximately 100 patients will be randomized to each of the 3 treatment groups. Previous experience with the oral formulation of xanomeline suggests that this sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog (p<.05 based on a standard deviation of 0.9." based on a standard deviation of 6.5. Furthermore this sample size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p<.05 two-sided) InterventionalStudyProtocolVersion.interventionGroupQuantity, Arm.targetAccrualNumberRange, and StudyProtocolVersion.targetAccrualNumberRange are all related to parts of the SampleSizeConsideration that are not yet fully modeled here. none false includingStatisticalAnalysisPlanVersion is included in Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan. false text A textual or media-based representation of the sample size consideration, including details needed to replicate sample size calculations. "Approximately 100 patients will be randomized to each of the 3 treatment groups. Previous experience with the oral formulation of xanomeline suggests that this sample size has 90% power to detect a 3.0 mean treatment difference in ADAS-Cog (p<.05 based on a standard deviation of 0.9." based on a standard deviation of 6.5. Furthermore this sample size has 80% power to detect a 0.36 mean treatment difference in CIBIC+ (p<.05 two-sided) Details included could be: difference to be detected, variability, assumptions. bridg:ScheduledActivity Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = "true" are valid. false ScheduledActivity An activity that is anticipated to occur at some time in the future and has been assigned a time or date when that activity is to be performed. An X-Ray scheduled for February 15 is in state "Scheduled." If John is unable to have the X-Ray on that date but "date" attribute would change) or moved to state "Canceled." the X-Ray would either be rescheduled (remain in "Scheduled" state Only BiologicEntity, BiologicEntityGroup, Material, ProductGroup or Organization (via Subject or ExperimentalUnit) with actualIndicator = "true" are valid. be participated in by actualIndicator Qualifier false dateRange The date and time span specifying when the activity is scheduled to begin and end. false idealDateRange The date and time span specifying when the activity was originally scheduled to begin and end. This would be the date and time span based on applying the study calendar to a specific subject. false repetitionNumber An integer that identifies the particular occurrence of a repeating activity. The first repetition is defined as '1'. 2 3 A PlannedActivity might have a repeatQuantity of 4 which would result in 4 ScheduledActivity with repetitionNumbers of 1 and 4 respectively. The ScheduledActivity will repeat at least the minimum number of times and at most, the maximum number of times as defined in PlannedActivity.repeatQuantity. false statusChangeReasonCode A coded value specifying why the status has changed. false statusCode A coded value specifying the phase in a lifecycle of a scheduled activity. "canceled" "performed"). "scheduled" For a lab test this would be the condition or stage in the lifecycle of the test (e.g. Please refer to the Scheduled Activity Status state transition diagram for further details. false statusDate The date (and time) on which the status is assigned to the activity. bridg:ScheduledNotification Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. Only Person or Organization (via NotificationReceiver) with actualIndicator = "true" is valid. false ScheduledNotification An activity that represents the communication of a message to a recipient that is anticipated to occur at some time in the future and has been assigned a time or date when that activity is to be performed. Associations from Subject (including StudySubject) are valid. Associations from ExperimentalUnit are not valid. be participated in by Qualifier Only Person or Organization (via NotificationReceiver) with actualIndicator = "true" is valid. be received by actualIndicator Qualifier false message The actual text scheduled to be included in the notification. This may mean that message variables have been replaced with actual data. false messageTitle The subject of the notification. bridg:ScheduledSubstanceAdministration Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. activeIngredientDose must only be used when the ScheduledSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. false ScheduledSubstanceAdministration An activity of applying, introducing or otherwise giving medications or other substances to a subject or experimental unit that is anticipated to occur at some time in the future. Administration of methotrexate as part of chemotherapy. Associations from Subject (including StudySubject) are valid only for BiologicEntity, BiologicEntityGroup and Specimen, not for Product, HealthcareFacility or Organization. Associations from ExperimentalUnit are valid for BiologicEntity, BiologicEntityGroup, BiologicEntityPart and Specimen, but not for Product or ProductGroup. be participated in by Qualifier activeIngredientDose must only be used when the ScheduledSubstanceAdministration is associated to a StudyAgent that has only one active ingredient. activeIngredientDose Qualifier bridg:Service false Service Labor support for research. and statistical management. data management protocol management registration management false typeCode A coded value specifying the kind of service. Data Coordinating Center Data Safety Monitoring Board (DSMB) Institutional Review Board (IRB) bridg:ServiceDeliveryLocation false ServiceDeliveryLocation A place at which services are provided by, or on behalf of, an organization. false code A coded value specifying the kind of service delivery location. clinical dedicated incidental non-clinical A service delivery location may be either an incidental service delivery location (a place at which services may be provided without prior designation or authorization) or a dedicated service delivery location (a place that is intended to house the provision of services). Dedicated service delivery locations can be further characterized as either clinical or non-clinical. none false locatedOrganization be delivery location for none false locatedPlace be located at false postalAddress A contact point used to send physical forms of communication to the service delivery location. false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the service delivery location. The set of digits that serves as the address for a telephone device. Included in the phone number are country, city, and area codes needed to uniquely address the telephone. A URL or e-mail would be similarly described. bridg:Specimen false Specimen Biologic specimen Product specimen A substance or portion of material originally obtained from an entity for use in testing, examination, or study. A DNA specimen extraction from a saliva specimen. A Formalin-Fixed A few grains of cattle feed obtained from a feed sack. A pooled blood sample that resulted from a mixing procedure performed on several blood samples taken from individual animals. A randomly selected pill from a blister pack. A serum specimen that resulted from Centrifugation procedure performed on a blood specimen. Blood obtained by a specimen collection activity performed on a study subject. Paraffin-Embedded (FFPE) block that resulted from a paraffin embedding procedure performed on a formalin fixed tissue specimen. false accessionNumberText An alphanumeric identifier (not necessarily unique to the specimen) assigned by a receiving lab to specimens that are received together as a set. true conditionCode A coded value specifying one of a discreet list of values describing the condition of the specimen at time of receipt at the lab. Hemolyzed Icteric Lipemic Derived from PerformedObservationResult.value(ANY=>CD).code WHERE PerformedObservationResult > PerformedObservation > DefinedObservation.nameCode = "assess specimen condition" none false performingMaterial is a function performed by none false producingPerformedSpecimenCollection be a result of false typeCode A coded value specifying the kind of the specimen derived from other specimens. aliquot isolate specimen bridg:StatisticalAnalysisPlan false StatisticalAnalysisPlan A plan that encompasses all aspects of statistical activity for a study, including any statistical statements made prior to or at protocol finalization. The Statistical Analysis Plan includes a more technical and detailed elaboration than described in the protocol of the principal features of the analyses, and detailed procedures for executing the statistical analyses of the primary and secondary variables and other data. The statistical analysis plan evolves during the course of the study. bridg:StatisticalAnalysisPlanDocumentVersion false StatisticalAnalysisPlanDocumentVersion A representation, conceptually a document, that is created to convey the statistical analysis plan version structured content to human beings. none false usedStatisticalAnalysisPlanVersion is created from Identifies the version of a statistical analysis plan that is the basis for a version of a statistical analysis plan document. bridg:StatisticalAnalysisPlanVersion The StatisticalAnalysisPlanVersion must pertain to the same StudyProtocolVersion that the StatisticalAnalysisPlan pertains to. false StatisticalAnalysisPlanVersion A point-in-time snapshot of a statistical analysis plan. The statistical analysis plan evolves during the course of the study and accordingly the snapshot may address a different issue at varying levels of detail relative to the final plan. The StatisticalAnalysisPlanVersion must pertain to the same StudyProtocolVersion that the StatisticalAnalysisPlan pertains to. addresses the needs of Qualifier none false addressedStudyProtocolVersion addresses the statistical needs of Identifies the version of the study protocol that is the basis for a statistical analysis plan version. false description The textual explanation of the statistical analysis plan version. false identifier A unique symbol that establishes the identity of a version of the statistical analysis plan. false typeCode A coded value specifying them kind of statistical analysis plan version. approved draft none false versionedStatisticalAnalysisPlan is a version of Identifies the statistical analysis plan that is the basis for a statistical analysis plan version. bridg:StatisticalAnalysisPlanVersionModificationSummary false StatisticalAnalysisPlanVersionModificationSummary Information about all changes made between the current and previous version of the statistical analysis plan. false date The date (and time) on which the modification took place. false reasonCode A coded value specifying the motivation, cause, or rationale for the modification. Actual analysis differed from planned Change in strategy Error correction New information available Request by FDA none false sourceStatisticalAnalysisPlanVersion has as source Identifies the changed version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary. none false targetStatisticalAnalysisPlanVersion has as target Identifies the original version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary. false text Textual or media-based summary of the changes. Another drug in the class has been approved so additional analyses of a new exploratory endpoint have been added. Distribution assumptions for some analyses were not met Site was non-compliant so additional analyses are needed to handle this site's data. so additional analyses were performed to check robustness of results. false timingDescription Text description of when the modification occurred relative to the study. Modification made prior to first subject's first visit Modification made prior to unblinding bridg:StatisticalAnalysisPlanVersionStatus false StatisticalAnalysisPlanVersionStatus Describes the state of the statistical analysis plan version. false code A coded value specifying the phase in the lifecycle of the statistical analysis plan version. active inactive false date The date that the statistical analysis plan version entered the current status. bridg:StratumGroup false StratumGroup A designation used to segregate study subjects into collections in order to balance the study for analysis. The stratum group is made up of a combination of stratification criterion answers, which ultimately is used to assign study subjects or experimental units to arms on a study. A given study may want to require even distribution of gender and age so stratum groups may be defined as: males under 18 and females 18 and over. females under 18 males 18 and over none false characterizingDefinedStratificationCriterionPermissibleResult is characterized by none false describingStudyProtocolVersion is defined by false description The textual representation of the stratum group. Baseline PSA Concurrent therapy Gleason score Patient age (years) Primary malignancy Weight loss severity false groupNumber An integer that identifies the stratum group to study personnel, such as the statistician and registrars. Disease Type Gender Patient age (years) Stratum A Treatment Cohort Two-year survival probability This index is used to cross-reference the stratum group and set of arms during registration. It is provided to perform a lookup in the randomization book or statistical algorithm when performing randomization. Text is captured using the originalText attribute of the INT.NONNEG data type. bridg:StudyActivity false StudyActivity The intention to use a defined activity in the design of a study. If a study's design includes the activity of taking blood pressure the DefinedActivity for blood pressure is linked to the study via this class. The number of times this activity occurs during the study and the relative timing for those occurrences is represented by PlannedActivity. false studyFocusIndicator Specifies whether the activity is a key investigational activity for a study. A study focused on investigating the effectiveness of a drug will flag the substance administration of the drug or a study focused on determining the average blood pressure of a certain population will flag the blood pressure observation. If a study has study agents, one or more of the study activities will presumably use the agent and have this indicator set to true. none false usedDefinedActivity uses none false usingStudyProtocolVersion is used by bridg:StudyAgent false StudyAgent A product that is being used or tested as part of a study. Artificial knee joints used in a joint replacement study. Fish oil used in a heart health study. Tamoxifen used in a breast cancer study. If a study has study agents, presumably one or more of the StudyActivity will use the agent and have studyFocusedIndicator = "true". false blindedName A non-unique textual identifier of a study agent to be used by participants from whom the identity of the study agent is hidden. This name is assigned within the context of a study so that products which blinded participants should not be able to distinguish between/among have the same blinded name. In a study for which the study agents are a drug product and a matching placebo In a study with two different investigational products and their matching placebos both the active product and the placebo might simply be called "Study Drug." the blinded names might be "Bottle A" and "Bottle B" or "100 mg tablet" and "25 mg tablet." false characteristicModifiedIndicator Specifies whether the agent's characteristic have been modified from those approved in the marketing authorization in a way that could affect its quality. Modification may include a change in pharmaceutical form (e.g. over-encapsulation, colour, dilution, re-tabletting for blinding etc.) or removal from the primary packaging and repacking (e.g. removal from a blister and putting in a bottle). none false evaluatingStudyProtocolVersion is evaluated by false expandedAccessIndicator Specifies whether the product (drug or device) is available for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled study. Expanded Access is a mechanism that provides non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. false firstInHumanIndicator Specifies whether this is the first time an active substance of the agent is to be administered to humans in a study. false firstInHumanRiskFactorCode A coded value specifying the risk factors identified with administering the agent's active substance to humans for the first time in a study. false functionCode A coded value specifying how this agent is used in the study. active control comparator agent lead agent placebo This is important to know in multi-agent studies. false pediatricFormulationIndicator Specifies whether the pharmaceutical form of the agent is intended for pediatric usage. A value of true may indicate that the agent is dissolvable or grape flavored to be easily ingested by the pediatric population. smaller none false performingProduct is a function performed by false statusCode A coded value specifying the phase in the lifecycle of the agent's association to a study. active cancelled complete pending false statusDate The date (and time) on which the status is assigned to the study agent. false substitutionAllowedIndicator Specifies whether this agent as identified by its active substance is permitted to be substituted by a local brand. The study protocol may specify the use of Paracetamol which could be substituted locally in the United States with any brand containing acetaminophen including Tylenol and Panadol. bridg:StudyCondition false StudyCondition A condition that is a focus of the study. false code A coded value specifying the condition that is the focus of the study. In a study to examine risk factors for Lupus but the target condition code would be a Lupus SNOMED code. might have as an inclusion criterion "healthy volunteer" none false focuses onStudyProtocolVersion is the focus of false leadIndicator Specifies whether this is the primary condition of a study. bridg:StudyExecution Only Organization (via StudyOversightAuthority) with actualIndicator = "true" is valid. Only Person or Organization (via StudyResource) with actualIndicator = "true" is valid. false StudyExecution An ongoing and/or past performance of a formal investigation as specified in a study protocol. The term "protocol" is somewhat overloaded and must be qualified to provide semantic context. Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization). The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship). The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyExecution and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time. - The StudyExecution class represents the conduct of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities. Only Organization (via StudyOversightAuthority) with actualIndicator = "true" is valid. be overseen by actualIndicator Qualifier Only Person or Organization (via StudyResource) with actualIndicator = "true" is valid. use actualIndicator Qualifier true effectiveDateRange Specifies the period of time over which the study was executed May specify the start and/or end or duration. This can be derived by looking at the StudyOverallStatus where low.value corresponds to the activation date and high.value corresponds to the completion date. true enrolledStudySubjectNumber An integer specifying the quantity of study subjects enrolled in the study at the current time. This can be derived by counting the number of enrolled subjects. none false instantiatingStudyProtocol is the execution of bridg:StudyInvestigator If the associated StudyProtocolVersion is an InterventionalStudyProtocolVersion then the StudyInvestigator must be a function performed by a HealthcareProvider. false StudyInvestigator A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. If the associated StudyProtocolVersion is an InterventionalStudyProtocolVersion then the StudyInvestigator must be a function performed by a HealthcareProvider. be a function performed by Qualifier false identifier A unique symbol that establishes identity of the study investigator. false signatureText The signed name of the investigator who is responsible for completing a form or report for a clinical study. A textual or multimedia depiction of the signature by which the participant endorses his or her participation in the activity as a specified role and that he or she agrees to assume the associated accountability. bridg:StudyLegalSponsor A StudyLegalSponsor is a function performed by one and only one of the following: HealthcareProvider, Organization. false StudyLegalSponsor A sponsor that initiates the investigation and is legally responsible for the study. Government Agency examples: National Cancer Institute (NCI) National Cancer Research Institute (NCRI) National Institutes of Health (NIH) Private industry examples: pharmaceutical companies A StudyLegalSponsor is a function performed by one and only one of the following: HealthcareProvider, Organization. be a function performed by Exclusive Or none false performingHealthcareProvider be a function performed by none false performingOrganization be a function performed by false primaryIndicator Specifies whether this is the main or principal study legal sponsor. none false sponsoredStudyProtocolVersion is responsible for bridg:StudyObjective false StudyObjective A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. To compare overall survival in subjects with [type of cancer] who have received [prior treatment] and who are randomized to treatment with either Combination A+B or single-agent B. To compare the proportion of subjects developing a rash in subjects administered dermatological precautions (DP) versus subjects administered usual care precautions (UC) during 12 weeks of treatment of Drug X in [disease description] subjects. To determine efficacy of Drug X dose 1 To extend the life of study participants by at least 3 years. To obtain exploratory descriptive information on the relationship of tobacco use To select a Drug X dose for further evaluation based on comparison of the short-term antiviral activity alcohol use and dietary patterns on toxicity and outcomes in males and females. and dose 3 as measured by the percentage of subjects experiencing headache relief. and tolerability of different oral doses of Drug X in combination with Drug Y in HIV-1 infected therapy-naïve subjects. dose 2 safety StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms). false description The textual representation of the study objective. The objective of the analysis is to evaluate the efficacy of study treatment versus placebo. The Alzheimer's Disease Assessment Scale - Cognitive Subscale and drug dose (0 and high dose [81 mg]). low dose [54 mg] total of 11 items [ADAS-Cog (11)] and the Video-referenced Clinician's Interview-based Impression of Change (CIBIC+) will serve as the primary efficacy instruments. Efficacy will be determined by testing for a statistically significant relationship between the change in both the ADAS-Cog (11) and CIBIC+ scores The example above makes reference to content from more than just the StudyObjective class, rather also from classes closely related to it. However, in prose presentation, this is common practice. See BRIDG GForge Tracker #30649 and #31401. none false involvingStudyProtocolVersion is an aim of false typeCode A coded value specifying the kind of study objective. exploratory primary secondary tertiary The examples given are the only allowable concepts for this attribute. bridg:StudyOutcomeMeasure At least one of the following must be mandatory for StudyOutcomeMeasure: name, typeCode. false StudyOutcomeMeasure Specific key measurement(s) or observation(s) used to measure the effect of experimental variables on the subjects in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. The specific measure that receives the most emphasis in assessment that would most specifically answer the hypothesis proposed by the study design. At least one of the following must be mandatory for StudyOutcomeMeasure: name, typeCode. Mandatory Attribute Qualifier false description The textual summary of the study outcome measure used to clarify its meaning, method, or purpose. none false measuredStudyObjective measures false name A non-unique textual identifier for the study outcome measure. all-cause mortality false primaryIndicator Specifies whether this is the main or principal study outcome measure. false timeFrameText Time point(s) at which the study outcome measure is assessed one year false typeCode A coded value specifying the kind of study outcome measure. bio-availability bio-equivalence efficacy n/a pharmacodynamics pharmacokinetics safety bridg:StudyOverallStatus false StudyOverallStatus Describes the comprehensive state of the study. The actual overall status of a study may be derived if it is possible to roll-up the site-specific status. false anticipatedIndicator Specifies whether the overall status of the study is an estimate. BRIDG SCC has made the decision to add an anticipatedIndicator until we learn the business rules of how the overall study status could be derived. false code A coded value specifying the phase in the lifecycle of the study as a whole. Active Administratively complete. Approved Closed to Accrual Closed to Accrual and Intervention Disapproved In Review Temporary Closed to Accrual Temporary Closed to Accrual and Intervention Withdrawn Please refer to the Study Overall Status state transition diagram for further details. The overall status of a study may overlap with the study site status and accrual status. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study recruitmentl status codes and adopt the CTRP values for study status code. false comment Additional description of the overall status of the study. false date The date (and time) on which the overall status of the study is assigned. none false describedStudyExecution describes false studyStoppedReasonCode A coded value specifying why the study has been halted or terminated (for suspended, terminated or withdrawn studies). bridg:StudyOversightAuthority At least one of the following classes must be known for a StudyOversightAuthority: StudyProtocolVersion, StudyExecution. false StudyOversightAuthority An organization with monitoring, regulatory, or supervisory authority over biomedical research at the local, regional, national, or international level for a particular study. At least one of the following classes must be known for a StudyOversightAuthority: StudyProtocolVersion, StudyExecution. oversee Mandatory Qualifier none false overseenStudyExecution oversee none false overseenStudyProtocolVersion oversee none false performingOversightAuthority is a function performed by bridg:StudyPersonnel A StudyPersonnel might be a function performed by one and only one of the following: ResearchStaff, HealthcareProvider. false StudyPersonnel A person who performs a particular role within the context of a specific study. Coordinating Investigator Public Queries Scientific Leadership Scientific Queries Study Chair Study Director Study Principal Investigator A StudyPersonnel might be a function performed by one and only one of the following: ResearchStaff, HealthcareProvider. be a function performed by Exclusive Or false effectiveDateRange The date and time span for when the study personnel is active. none false performedStudyExecution perform a role for none false performingResearchStaff be a function performed by none false performingStudyProtocolVersion perform a role for false postalAddress A contact point used to send physical forms of communication to the study personnel. false primaryIndicator Specifies whether this is the main or principal study personnel. roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Investigator" and primaryIndicator ="true". false roleCode A coded value specifying the type of responsibility of the study personnel. Coordinating Investigator Public Queries Registrar Scientific Leadership Scientific Queries Study Chair Study Coordinator. Study Director Study Principal Investigator roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Investigator" and primaryIndicator ="true". false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of the study personnel. bridg:StudyProtocol false StudyProtocol A discrete, structured plan (that persists over time) of a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. The term "protocol" is somewhat overloaded and must be qualified to provide semantic context. Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization). The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship). The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyExecution and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time. - The StudyExecution class represents the conduct of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities. bridg:StudyProtocolDocument false StudyProtocolDocument A representation of the study protocol (that persists over time) in document form. The term "protocol" is somewhat overloaded and must be qualified to provide semantic context. Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization). The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship). The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyExecution and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time. - The StudyExecution class represents the conduct of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities. none false representedStudyProtocol represents bridg:StudyProtocolDocumentVersion For a given StudyProtocolDocumentVersion, the StudyProtocol represented by the StudyProtocolDocument being versioned as the StudyProtocolDocumentVersion must be the same as the StudyProtocol whose StudyProtocolVersion is contained by the StudyProtocolDocumentVersion. Only Person (via HealthcareProvider or ResearchStaff) with actualIndicator = "true" is valid for the DocumentAuthor of a StudyProtocolDocumentVersion. false NOTE: BRIDG SCC acknowledges that there are two ways to represent the relationship between a study protocol and a document that is cited by the study protocol: 1) use the StudyProtocolVersion to StudyReference association; 2) use the StudyProtocolVersion > StudyProtocolDocumentVersion > DocumentVersionRelationship associations. The first is more direct and uses domain terminology, while the second is more consistent with other document-to-document associations. The SCC hopes to clarify this ambiguity in a future release when a project dealing with publications or a related area comes to harmonization. StudyProtocolDocumentVersion Amendment A representation of a particular edition or snapshot of a document containing a study protocol as it exists at a particular point in time. Version 3 of a breast cancer protocol. The term "protocol" is somewhat overloaded and must be qualified to provide semantic context. Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization). The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship). The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyExecution and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time. - The StudyExecution class represents the conduct of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities. The term "Amendment" needs to be disambiguated since it sometimes refers to the amended version of the protocol (StudyProtocolDocumentVersion) and other times refers to the summary of changes (AmendmentChangeSummaryVersion). For a given StudyProtocolDocumentVersion, the StudyProtocol represented by the StudyProtocolDocument being versioned as the StudyProtocolDocumentVersion must be the same as the StudyProtocol whose StudyProtocolVersion is contained by the StudyProtocolDocumentVersion. is a version of Qualifier Only Person (via HealthcareProvider or ResearchStaff) with actualIndicator = "true" is valid for the DocumentAuthor of a StudyProtocolDocumentVersion. DocumentAuthor actualIndicator Qualifier false publicDescription The textual summary of a document intended for the general population. false publicTitle The title of the document intended for the general population. false scientificDescription The textual summary of a document that includes extended scientific or technical information. bridg:StudyProtocolVersion Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid. false StudyProtocolVersion A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. The term "protocol" is somewhat overloaded and must be qualified to provide semantic context. Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization). The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship). The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyExecution and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time. - The StudyExecution class represents the conduct of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities. Only Person or Organization (via StudyLegalSponsor) with actualIndicator = "true" is valid. be the responsibility of actualIndicator Qualifier false accrualReportingMethodCode A coded value specifying the technique that is used for reporting study subject accrual data to the study sponsor. abbreviated complete false acronym The non-unique initials or abbreviated name used for identification of the study. WHI for Women's Health Initiative false adaptiveDesignIndicator Adaptive Study Indicator Specifies whether the design of the study is expected to evolve during the execution of the study. false aeCodingSystem The coding system used for recording adverse events for a study. false amendmentGracePeriod The period of time during which sites can continue to accrue on an existing study version before they are required to switch to the new study version. 90 days false companionCode A coded value specifying the type of ancillary study. Embedded Non-Companion/Independent: This study is documented and executed on its own and does not support co-execution with a master study. This kind of study may be a master study with companion studies of its own. Non-Embedded Non-Stand-Alone Companion: This study is documented separately from a master study Non-Stand-Alone Companion: This study is part of a master study and cannot be executed separately from it nor in association with another master study. The documentation for this kind of companion study is embedded in the protocol of the master study. Stand-Alone Companion: This study is a separately documented study that can be performed on its own or as a companion to one or more master studies. but must be performed as part of a master study or as part of several master studies. Changes to example codes will require revisiting the RIM-based BRIDG Model. false conditionCodingSystem The coding system used for recording conditions that are the focus of a study. false delayedRegistryPostingIndicator Specifies whether there is to be a delay in the public disclosure of the study, as permitted by relevant local legislation or regulation. The study includes a device NOT previously approved or cleared by the US FDA for any use, as specified in US Public Law 110-85, Title VIII, Section 801. Select Yes/No. If "Yes" is selected, full posting of the trial information on ClinicalTrials.gov will be delayed until after the device has been approved or cleared. At that time, it is the registrant's responsibility to change this selection to "No" and release the record for full publication. false designConfigurationCode A coded value specifying how subject or experimental unit exposures to treatment strategies (which may include controls such as no treatment) will be identified, for retrospective studies, or planned, for prospective studies, in order to characterize treatment effects and compare effects of different treatment strategies in a clinical or pre-clinical study. The configuration will specify whether a subject or experimental unit received or is to receive only one exposure or multiple exposures, and, if multiple exposures, whether those exposures were/are to be simultaneous or in series. Case-control Case-crossover Case-only Cohort Crossover Design Ecologic or Community Studies Factorial Designs Family-based Parallel Group Design The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. false mandatoryIndicator Specifies whether the modifications contained in the study protocol version must be applied to all sites and subjects or study subjects that want to continue participating in the study. false multiInstitutionIndicator Specifies whether a study is designed to be conducted at more than one site concurrently. This could be conceived as derivable, but since it needs to be defined before study sites are associated with a study, it is needed here. Derived when StudyProtocolVersion.participatingOrganizationTypeCode = "Multi Center". Traditionally, the domain concept for this attribute is called "Multi-Institution" indicator, but the intent is to identify whether there will be multiple sites which will have separate IRB approvals, personnel training, regulatory affairs, consistent use of procedures, etc. So if a given institution has multiple sites associated with it and does IRB approval at the institution level, but has more than one site involved in the study, even if all the sites are part of the same institution, it is still multiInstitutionIndicator = "true". false participatingLocationCode participating countries participating states A coded value specifying the locations from which participants will be, are intended to be, or have been recruited for the study. false participatingOrganizationTypeCode A coded value specifying the kind of organizations planned to participate as study sites for this study. Cancer Center Clinical Center Consortium Group Intergroup Multi-Center Network Single Institution false periodicTargetAccrualNumber A ratio representing the number of study subjects to be accrued per a specified amount of time. For monthly target accrual a given study may have a target accrual of 100 per 1 month meaning the numerator of the ratio is the integer 100 and the denominator is a PQ where the value is 1 and the unit is month. false phaseCode A coded value specifying a stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. I I/II II III N/A Studies are generally categorized into four (sometimes five) phases described separately herein. An investigational medicine or product may be evaluated in two or more phases simultaneously in different studies, and some studies may overlap two different phases. Phase 1: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. Phase 2: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 3: Studies are expanded controlled and uncontrolled. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3b: Phase 3b studies are a sub category of phase 3 near the time of approval to elicit additional findings. Phase 4: Concurrent with marketing approval, Food and Drug Administration (FDA) may seek agreement from the sponsor to conduct certain post-marketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. Phase 5: Post-marketing surveillance is sometimes referred to as Phase 5. false plannedDuration The intended period of time for the study. false plannedSiteNumberRange An integer falling within minimum and maximum bounds that specifies how many study sites are expected to participate in the conduction of the study. Relevant before specific sites have been selected. Can be derived once sites have been selected. false plannedStudySubjectExperience A description of what the study subject can expect to experience over the course of the study, including the sequence and duration of activities. The description and single- and double-blind treatment epochs. including pre-randomization and post-treatment epochs sequence and duration of study epochs therapy withdrawal epochs false populationDescription The textual representation of the subject characteristics, including inclusion and exclusion criteria and describes the population for which the study may be generalized. This would include all subgroups as well. false primaryPurposeTypeCode A coded value specifying the type of study based upon the intent of the study's activities. A classification of the intent of the study. Diagnostic studies are conducted to find better tests or procedures for diagnosing a particular disease or condition. Prevention studies look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines Quality of Life studies (or Supportive Care studies) explore ways to improve comfort and the quality of life for individuals with a chronic illness. Screening studies test the best way to detect certain diseases or health conditions. Treatment studies test new treatments minerals new combinations of drugs or lifestyle changes. or new approaches to surgery or radiation therapy. vaccines vitamins StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms). false purposeStatement A statement describing the overall intent of the study. This field describes the contribution of this study to product development, treatment strategies, prevention approaches, diagnostic techniques, or patient quality of life, i.e., what knowledge is being contributed from the conduct of this study. test the efficacy of a particular cancer treatment StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms). false responsiblePartyCode A coded value specifying the type of entity who is legally responsible for the execution of the study. PI sponsor false studySchematic Diagram which outlines all study epochs, timing of randomization and duration of treatments. false studySubjectTypeCode A coded value specifying the kind of study subject involved in the study or investigation. human mouse rat x-ray machine This attribute is explicitly not meant to represent parts of study subjects that may be studied, such as a human eye, or groups of study subjects such as a herd of cows. It is meant to represent the whole individual that is registered as a study subject. false targetAccrualNumberRange An integer falling within minimum and maximum bounds that specifies how many study subjects are to be accrued for the study. A typical target accrual number (always assumed to be a minimum target) would be targetAccrualNumberRange.IVL<INT>.low, a maximum target accrual would be targetAccrualNumberRange.IVL<INT>.high. false targetAnatomicSiteCode A coded value specifying the anatomic location that is the focus of a study. breast ovary Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. false therapeuticAreaCode A coded value specifying the field of knowledge that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. eye disease nervous system disease none false versionedStudyProtocol is a version of bridg:StudyRecruitmentStatus false StudyRecruitmentStatus Status of finding and enrolling appropriate study subjects (those selected on the basis of the protocol's inclusion/exclusion criteria) into a study. false code A coded value specifying the phase in the lifecycle of recruitment for the study. Not yet recruiting; recruiting; enrolling by invitation; active not recruiting; completed; suspended; terminated; withdrawn. The recruitment status of a study may overlap with the study site status and accrual status. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study recruitment status codes and adopt the CTRP values for study status code. false date The date (and time) on which the recruitment status is assigned. none false describedStudyExecution describes bridg:StudyReference At least one of the following must be mandatory for StudyReference: publicationIdentifier, publicationName, uniformResourceLocator, citationDescription, linkpageDescription. false NOTE: BRIDG SCC acknowledges that there are two ways to represent the relationship between a study protocol and a document that is cited by the study protocol: 1) use the StudyProtocolVersion to StudyReference association; 2) use the StudyProtocolVersion > StudyProtocolDocumentVersion > DocumentVersionRelationship associations. The first is more direct and uses domain terminology, while the second is more consistent with other document-to-document associations. The SCC hopes to clarify this ambiguity in a future release when a project dealing with publications or a related area comes to harmonization. StudyReference A citation to a publication related to the protocol's background. CT.gov instruction say to provide either the unique PubMed Identifier (PMID) of an article or enter the full bibliographic citation. At least one of the following must be mandatory for StudyReference: publicationIdentifier, publicationName, uniformResourceLocator, citationDescription, linkpageDescription. Mandatory Attribute Qualifier false citationDescription A bibliographical reference in a format acceptable to the publisher of the reference material. Studies performed in the United States may be required to conform to the National Library of Medicine's MEDLINE format. false linkPageDescription The textual representation of the linked page. If the page being linked is the protocol's home page on the sponsor's Web site the description might be "This is a link to the study sponsor's web site". false publicationIdentifier A unique symbol that establishes identity of a publication related to the study protocol background. 10987815 is the unique PubMed Identifier (PMID) for the citation in MEDLINE. false publicationName A non-unique textual identifier specifying the human-readable name of the publication. MEDLINE is the source for PMID 10987815 none false referencedStudyProtocolVersion is referenced by false uniformResourceLocator A complete reference to a website (including http://) that is directly relevant to the study. http://www.alzheimers.org/ bridg:StudyRegistry false StudyRegistry An organization (typically a government agency) that administers the registration of studies. ClinicalTrials.gov (CT.gov) Netherlands National Trial Register (NTR) The study registry should contain basic information about each study sufficient to inform potential subjects (and their healthcare providers) how to enroll in the study. false acronym The non-unique initials or abbreviated name used for identification of the registry. NTR (Netherlands National Trial Register) none false managingOrganization be managed by false name A non-unique textual identifier for the registry. ClinicalTrials.gov bridg:StudyResearchCoordinator false StudyResearchCoordinator At some sites (primarily in academic settings) Clinical Research Coordinators are called (Clinical Research Associates) CRAs. clinical coordinator protocol nurse research coordinator research nurse study coordinator A person who handles the administrative responsibilities of a study on behalf of the study investigator, acts as a liaison between study site and study sponsor, and reviews all data and records before a monitor's visit. bridg:StudyResource false StudyResource The association between a resource and the study on which it is used. false effectiveDateRange The date and time span for when the study resource is active. false inactiveComment Additional description why the resource is no longer active. false primaryIndicator Specifies whether this is the main or principal study resource. This distinguishes between an organization that is the primary funder vs. a funder who provides less money for a study. none false usedResource uses none false usingStudyExecution be used for none false usingStudyProtocolVersion be used for bridg:StudySite A StudySite is a function performed by one and only one of the following: HealthcareFacility or Organization (serving as a StudySite but is not a HealthcareFacility). At least one of the following must be known for a StudySite: StudySiteProtocolVersionRelationship, StudyExecution. Only Organization (via HealthcareFacility or direct association) with actualIndicator = "true" is valid. Only Organization (via OversightCommittee) with actualIndicator = "true" is valid. false StudySite A facility in which study activities are conducted. The site where the study subject encounter occurs or the site of the Investigator. A StudySite is a function performed by one and only one of the following: HealthcareFacility or Organization (serving as a StudySite but is not a HealthcareFacility). be a function performed by Exclusive Or At least one of the following must be known for a StudySite: StudySiteProtocolVersionRelationship, StudyExecution. execute Mandatory Qualifier Only Organization (via HealthcareFacility or direct association) with actualIndicator = "true" is valid. be a function performed by actualIndicator Qualifier Only Organization (via OversightCommittee) with actualIndicator = "true" is valid. be overseen by actualIndicator Qualifier false accrualStatusCode A coded value specifying the phase in the lifecycle of a participating site relative to the enrollment of additional experimental units in the given study. Closed to accrual Open to accrual Pending accrual Temporarily closed to accrual Please refer to the Study Site Accrual Status state transition diagram for further details. The accrual status of a study site may overlap with the overall status of the study and study site status. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study site accrual status codes and adopt the CTRP values for study site status code. false accrualStatusDate The date (and time) on which the accrual status is established. false dateRange The date and time span specifying when the site's participation in the study begins and ends. none false executedStudyExecution execute false identifier A unique symbol that establishes identity of the study site. false leadIndicator Specifies whether this is the principal administrative organization responsible for the study. Exception: A multi-site study with no single assigned coordination center; in this case, every participating organization can be named as lead organization. none false performingHealthcareFacility be a function performed by none false performingOrganization be a function performed by false plannedDuration The intended period of time for the study site's participation in the study. false statusCode A coded value specifying the phase in the lifecycle of the study site. Active Administratively complete. Approved Closed to Accrual Closed to Accrual and Intervention Disapproved In Review Temporary Closed to Accrual Temporary Closed to Accrual and Intervention Withdrawn active cancelled complete pending The status of a study site may overlap with the study site accrual status and overall status of the study. This overlap needs to be clearly differentiated. (See tracker issue 29398). A proposed solution is to eliminate the study site accrual status codes and adopt the CTRP values for study site status code. false statusDate The date (and time) on which the status is assigned to the study site. false targetAccrualNumberRange An integer falling within minimum and maximum bounds that specifies how many experimental units are needed for enrollment at this site. bridg:StudySiteInvestigator If the associated StudyProtocolVersion is an InterventionalStudyProtocolVersion then the StudySiteInvestigator must be a function performed by a HealthcareProvider. false StudySiteInvestigator A researcher at a study site who oversees multiple aspects of the study at a site, including protocol submission for IRB approval, participant recruitment, informed consent, data collection, and analysis. If the associated StudyProtocolVersion is an InterventionalStudyProtocolVersion then the StudySiteInvestigator must be a function performed by a HealthcareProvider. be a function performed by Qualifier false identifier A unique symbol that establishes identity of the study site investigator. Open issue: Need to know if this is actually an identifier specifically assigned to an investigator specific to a particular study and site. bridg:StudySiteOversightStatus Only Organization (via OversightCommittee) with actualIndicator = "true" is valid. false StudySiteOversightStatus Describes the state of a study at a particular site as assigned by an oversight committee. approved; submitted denied; submission not required. exempt; submitted pending; submitted request not submitted; submitted Only Organization (via OversightCommittee) with actualIndicator = "true" is valid. be assigned by actualIndicator Qualifier none false assigningOversightCommittee be assigned by none false describedStudySiteProtocolVersionRelationship describes false reviewBoardApprovalNumberText A character string that is assigned by the review board upon approval of the protocol. false reviewBoardProcessCode A coded value specifying the phase in the lifecycle of the review board process. approved; submitted denied; submission not required exempt; submitted pending; submitted request not submitted; submitted Please refer to the Review Board Process Status state transition diagram for further details. false reviewBoardProcessDate Review Board Approval Date The date (and time) on which the Institutional Review Board (IRB) determined the status of this study protocol for execution at this site. bridg:StudySitePersonnel A StudySitePersonnel is a function performed by one and only one of the following: ResearchStaff, HealthcareProvider. false StudySitePersonnel A person who performs a particular role within the context of a specific study site. Study Site Investigator Study Site Research Coordinator roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Site Investigator" and primaryIndicator ="true". A StudySitePersonnel is a function performed by one and only one of the following: ResearchStaff, HealthcareProvider. be a function performed by Exclusive Or false effectiveDateRange The date and time span for when the study site personnel is active. none false performedStudySite perform a role for none false performingResearchStaff be a function performed by false postalAddress A contact point used to send physical forms of communication to the study site personnel. false primaryIndicator Specifies whether this is the main or principal study site personnel. roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Site Investigator" and primaryIndicator ="true". false roleCode The coded value specifying a type of responsibility of the study site personnel. Facility Principal Investigator Sub Investigator roleCode and primaryIndicator are redundant attributes when roleCode = "Principal Site Investigator" and primaryIndicator ="true". none false supportedPlannedStudySite plan to perform a role for false telecomAddress A sequence of digits or characters used to identify a particular telephone, fax, or email of a study site personnel. bridg:StudySiteProtocolVersionRelationship false StudySiteProtocolVersionRelationship Specifies the link between a study site and a version of the study protocol used or available for use at that site. Even if a study site's IRB has not reviewed the study protocol version, if there is a new version for the study protocol, then there is the potential for a relationship between the site and the version. The dateRange is specified only if the version is approved for this site by the IRB and activated at the site. Retroactive approval means that the dateRange does not have to be on or after the IRB approval date. false effectiveDateRange The date and time span specifying when the relationship between a study site and protocol version begins and ends. none false executedStudyProtocolVersion executes none false executingStudySite is executed at bridg:StudySiteRecruitmentStatus false StudySiteRecruitmentStatus The point-in-time expression of the progress of finding and enrolling study subjects into a study for a particular study site. false code A coded value specifying the phase in the lifecycle of recruitment for the study site. Not yet recruiting; recruiting; enrolling by invitation; active not recruiting; completed; suspended; terminated; withdrawn. The recruitment status of a study may overlap with the study site status and accrual status. This overlap needs to be clearly differentiated. (See tracker issue 29398). false date The date (and time) on which the study site recruitment status is assigned. bridg:StudySiteResearchCoordinator false StudySiteResearchCoordinator At some sites (primarily in academic settings) StudySiteResearchCoordinators are called Clinical Research Coordinators or Clinical Research Associates (CRAs). clinical coordinator protocol nurse. research coordinator research nurse study coordinator A person who handles the administrative responsibilities of a study on behalf of a study site, acts as a liaison between the study site and the study investigator and/or study sponsor, and reviews all data and records before a monitor's visit. bridg:StudySiteResource false StudySiteResource The association between a resource and the study site on which it is used. bridg:StudySpecificStatisticalAnalysisPlan false StudySpecificStatisticalAnalysisPlan A type of statistical analysis plan that is intended to draw conclusions from only one study. none false addressedStudyProtocol addresses the statistical needs of Identifies the study protocol whose data is used in the study specific statistical analysis plan. bridg:StudySubject Association from Organization is not valid. false StudySubject A physical entity which is the primary unit of operational and/or administrative interest in a study. A pacemaker A person who is registered in a study as a recipient of an investigational product or as a control. Individuals participating in observational or other studies. Individuals who are being screened for studies. a cow a fuse that can be used in medical devices a pen of pigs or a tissue sample from a tissue bank. StudySubjects within a study are all of the same type. An entity registered in a study is not part of another entity registered in the same study. Association from Organization is not valid. be a function performed by Not Applicable false confidentialityIndicator Specifies whether the study subject, or their legally acceptable representative, has not authorized the use and disclosure of their protected health information (i.e., the study subject's data is private and confidential). false paymentMethodCode A coded value specifying the primary payer/insurance carrier information at the time of treatment on a study. Medicaid Medicare Medicare And Private Insurance Private Insurance false statusCode A coded value specifying the phase in the lifecycle of the study subject. candidate eligible follow-up ineligible not registered off-study on-study pending on-study potential candidate screening withdrawn Please refer to the Study Subject Status state transition diagram for further details. false statusDate The date (and time) on which the status is assigned to the study subject. bridg:StudySubjectExperienceDocumentVersion Only BiologicEntity, BiologicEntityGroup, Material (via StudySubject) with actualIndicator = “true” is valid. false StudySubjectExperienceDocumentVersion A document capturing the actual end-to-end (or beginning to point-in-time) experience of a single study subject within the context of a particular study Only BiologicEntity, BiologicEntityGroup, Material (via StudySubject) with actualIndicator = “true” is valid. be participated in by actualIndicator Qualifier bridg:StudySubjectProtocolVersionRelationship false StudySubjectProtocolVersionRelationship Specifies the link between a study subject and a version of the study protocol at a site. none false assigningStudySiteProtocolVersionRelationship is assigned to none false assigningStudySubject is the assigned version for false effectiveDateRange The date and time span specifying when the relationship between a study subject and protocol version begins and ends. bridg:Subject A Subject might be a function performed by one and only one of the following: BiologicEntity, BiologicEntityGroup, HealthcareFacility, Organization, Product, Specimen. false Subject An entity of interest, either biological or otherwise. A human being who might be of interest because they are on a study a sheep who might have experienced an adverse event or a pacemaker that failed. A Subject might be a function performed by one and only one of the following: BiologicEntity, BiologicEntityGroup, HealthcareFacility, Organization, Product, Specimen. be a function performed by Exclusive Or none false performingBiologicEntity be a function performed by none false performingProduct be a function performed by none false performingSpecimen be a function performed by bridg:SubjectIdentifier A SubjectIdentifier is assigned by one and only one of the following: Organization, SystemOfRecord, DonorRegistry. Only BiologicEntity, BiologicEntityGroup, Organization (via Subject), Material (via Product, Specimen) with actualIndicator = "true" is valid. Only Organization with actualIndicator = "true" is valid. false SubjectIdentifier The unique identification of a subject in a specified context. study subject number 7 on a specific study This class is a resolution of the requirement for noting the type of an identifier which is not handled by the purely technical HL7 II data type. A SubjectIdentifier is assigned by one and only one of the following: Organization, SystemOfRecord, DonorRegistry. be assigned by Exclusive Or Only BiologicEntity, BiologicEntityGroup, Organization (via Subject), Material (via Product, Specimen) with actualIndicator = "true" is valid. identifies actualIndicator Qualifier Only Organization with actualIndicator = "true" is valid. be assigned by actualIndicator Qualifier none false assigningOrganization be assigned by none false assigningSystemOfRecord be assigned by false effectiveDateRange The date (and time) span for when the subject identifier is active. none false identifiedSubject identifies false identifier A unique symbol that establishes identity of the subject. study subject number 7 on a specific study false primaryIndicator Specifies whether this is the main or principal subject identifier. false typeCode A coded value specifying the kind of subject identifier. cross study identifier study level subject identifier study site level subject identifier bridg:Submission A Submission must have one or more ReviewableUnit or SubmissionUnit but not both. Only Product with actualIndicator = "false" is valid. false Submission A compilation of the contents of one or more submission units that supports a specific regulatory purpose or decision. A request for approval to either market a product or to allow the applicant to start testing of a proposed product. In most cases, the compilation of the submission units is used to assess a product's quality, safety and effectiveness. Submissions are always associated with some regulatory action (or inaction). Each submission contains their own regulatory action. Submissions (e.g., initial marketing application, supplemental marketing application) would generally be comprised of multiple submissions units. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. A Submission must have one or more ReviewableUnit or SubmissionUnit but not both. groups Exclusive Or Only Product with actualIndicator = "false" is valid. has as subject actualIndicator Qualifier none false describedProduct has as subject none false evaluatingRegulatoryAssessment be evaluated in none false groupingRegulatoryApplication is grouped by true receiptDate The date (and time) on which the first submission unit is received by the regulatory authority. Derived from the transmission of the first SubmissionUnit to a RegulatoryAuthority. The first transmission is a new SubmissionUnit, Submission and RegulatoryApplication. The first submission of a SubmissionUnit starts a regulatory clock and that is how Submission.receiptDate is derived. Subsequent SubmissionUnits are considered either amendments or supplements to the Submission and/or RegulatoryApplication and the dates for those SubmissionUnits are for tracking purposes and do not set the regulatory time clock. false statusCode A coded value specifying the phase in the lifecycle of the submission. active withdrawn Please refer to the Submission Status state transition diagram for further details. false statusDate The date (and time) on which the status is assigned to the submission. none false submittingRegulatoryApplicationSponsor is submitted by false typeCode A coded value specifying the kind of submission. annual report original supplement bridg:SubmissionUnit A SubmissionUnit might be grouped into one and only one of the following: Submission, ReviewableUnit. false NOTE: Until further clarification, the BRIDG SCC believes the IND/IDE regulatory application serial number is the number assigned by the applicant/sponsor to a document that is either a supplement or an amendment to the original submission unit and is represented using DocumentIdentifier.identifer. SubmissionUnit The collection of documents provided to the regulatory authority at one time. A submission unit is made up of one to many document versions. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document versions. In the dynamic aspects of the model, a submission unit is one message that may have a collection of many document versions. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit. A SubmissionUnit might be grouped into one and only one of the following: Submission, ReviewableUnit. be grouped into Exclusive Or false effectiveDateRange The date and time span for when the submission unit is active. none false groupingReviewableUnit be grouped into none false groupingSubmission be grouped into none false includedDocumentVersion includes false receiptDate The date (and time) on which the submission unit is received by the regulatory authority. Typically, this date will start a review clock, if applicable. The combination of the typeCode and where the SubmissionUnit was received will determine the deadline for the SubmissionUnit to be reviewed. false typeCode A coded value specifying the kind of submission unit. amendment original supplement Typically each submission unit type would cause a different regulatory request. bridg:SubstanceExtractionAdministrationRelationship false SubstanceExtractionAdministrationRelationship Specifies the link between an extraction (performed substance extraction) of a biologic product and the administration (performed substance administration) of that biologic product. false donorTypeCode A coded value specifying the kind of donor that is used. HLA-identical sibling HLA-matched other relative HLA-mismatched relative Syngeneic Unrelated donor false relationCode A coded value specifying the self-relationship of the source to the target. Allogeneic Unrelated Allogeneic-related Autologous (self) This is not a familial relationship. bridg:SupplementalStatisticalAnalysisPlanVersion false SupplementalStatisticalAnalysisPlanVersion A type of statistical analysis plan version that provides specification for additional analyses not included as part of the principal statistical analysis plan version. Additional analyses during clinical study report preparation Analysis plan for sub-study or study addendum Hypothesis generation Pre-specified PK analysis plan Response to regulatory request false reasonCode A coded value specifying the motivation, cause, or rationale for the supplemental statistical analysis plan. Additional analyses during clinical study report preparation Hypothesis generation Response to regulatory request This coded concept is extensible, but the examples above cover a large proportion of possible values. bridg:SystemOfRecord false SystemOfRecord The system that assigned the identifier. This concept will be re-visited again in the next release. It may be an implementation-oriented concept. false name A non-unique textual identifier for the system that assigned the identifier. bridg:TargetAnatomicSite false TargetAnatomicSite An anatomic location that is the focus of an observation result. arm for skin rash brainstem spinal cord for a lesion false code A coded value specifying the anatomic location that is the focus of an observation result. arm for skin rash. brain stem or spinal cord for a lesion The target site of the result may be different than the target site of the activity (PerformedObservation) that generated it. For example, a chest x-ray (observation) has the target site of chest while the result might show an infiltration in the left lower lobe of the lung (target site of result), or a dermatological exam may check the skin across the whole body (target site of observation) while the result might identify a rash on the right leg (target site of result). Sources that capture anatomic site and laterality separately should map both to this attribute. For implementation models based on BRIDG where site and laterality are captured separately, you may wish to capture both concepts as a post-coordinated code structure or as multiple code repetitions. bridg:TreatingSite A TreatingSite might be associated to one and only one of the following: CooperativeGroupMember, CooperativeGroup. false TreatingSite Any healthcare facility where care is provided as part of a cooperative group organizational network. A cancer center that is part of the North Central Cancer Treatment Group (NCCTG). There are two ways a TreatingSite can be associated to a CooperativeGroup: either directly or through a CooperativeGroupMember. A TreatingSite might be associated to one and only one of the following: CooperativeGroupMember, CooperativeGroup. be a member of Exclusive Or Dave Beckett Nikki Rogers Participants in W3C's Semantic Web Deployment Working Group. Alistair Miles Sean Bechhofer An RDF vocabulary for describing the basic structure and content of concept schemes such as thesauri, classification schemes, subject heading lists, taxonomies, 'folksonomies', other types of controlled vocabulary, and also concept schemes embedded in glossaries and terminologies. SKOS Vocabulary The Friend of a Friend (FOAF) RDF vocabulary, described using W3C RDF Schema and the Web Ontology Language. Friend of a Friend (FOAF) vocabulary An AIM chat ID AIM chat ID testing An ICQ chat ID ICQ chat ID testing A jabber ID for something. jabber ID testing The sha1sum of the URI of an Internet mailbox associated with exactly one owner, the first owner of the mailbox. sha1sum of a personal mailbox URI name testing An MSN chat ID MSN chat ID testing A name for some thing. name testing A Yahoo chat ID Yahoo chat ID testing