ResearchStudy Mappings

• ResearchStudy: BRIDG5.1=ObservationalStudyProtocolVersion; Study; StudyProtocolVersion; v2=OBX; rim=Observation[classCode=CLNTRL, moodCode=EVN]; w5=clinical.diagnostics
• ResearchStudy.identifier: clinicaltrials-gov=Organization's Unique Protocol ID; Secondary IDs; w5=FiveWs.identifier; BRIDG5.1=No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic); rim=.identifier
• ResearchStudy.title: clinicaltrials-gov=Brief Title; BRIDG5.1=No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
• ResearchStudy.protocol: clinicaltrials-gov=Interventions; Arm/Intervention Cross-Reference; BRIDG5.1=StudyProtocolDocumentVersionPublicTitle.name; rim=.outboundRelationship[typeCode=DEFN].target
• ResearchStudy.partOf: BRIDG5.1=CompanionStudyRelationship; rim=.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
• ResearchStudy.status: w5=FiveWs.status; BRIDG5.1=StudyOverallStatus.code; rim=.status
• ResearchStudy.primaryPurposeType: BRIDG5.1=StudyProtocolVersion.primaryPurposeTypeCode
• ResearchStudy.phase: clinicaltrials-gov=Study Phase; BRIDG5.1=StudyProtocolVersion.phaseCode
• ResearchStudy.studyDesign: clinicaltrials-gov=Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention; BRIDG5.1=InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
• ResearchStudy.condition: clinicaltrials-gov=Conditions; w5=FiveWs.what[x]; BRIDG5.1=StudyCondition.code
• ResearchStudy.keyword: clinicaltrials-gov=Keywords; BRIDG5.1=DocumentVersion.keywordCode; DocumentVersion.keywordText
• ResearchStudy.region: BRIDG5.1=StudyProtocolVersion.participatingLocationCode
• ResearchStudy.description: clinicaltrials-gov=Detailed Description; BRIDG5.1=StudyProtocolDocumentVersion.publicDescription
• ResearchStudy.period: clinicaltrials-gov=Study Start Date (start); Study Completion Date (end); w5=FiveWs.done[x]; BRIDG5.1=ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration; rim=.effectiveTime
• ResearchStudy.site: clinicaltrials-gov=Facility; w5=FiveWs.where[x]; BRIDG5.1=PlannedStudySite; StudySite
• ResearchStudy.note: BRIDG5.1=No BRIDG mapping; rim=.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
• ResearchStudy.whyStopped: clinicaltrials-gov=Why Study Stopped; w5=FiveWs.why[x]; BRIDG5.1=StudyOverallStatus.studyStoppedReasonCode
• ResearchStudy.recruitment: clinicaltrials-gov=Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria); w5=FiveWs.subject; BRIDG5.1=InterventionalStudyProtocol.interventionGroupQuantity; rim=.participation[typeCode=SBJ].role
• ResearchStudy.recruitment.actualGroup: clinicaltrials-gov=Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria); w5=FiveWs.subject; BRIDG5.1=InterventionalStudyProtocol.interventionGroupQuantity; rim=.participation[typeCode=SBJ].role
• ResearchStudy.comparisonGroup: clinicaltrials-gov=Arms; BRIDG5.1=Arm
• ResearchStudy.objective: BRIDG5.1=StudyObjective
• ResearchStudy.objective.name: BRIDG5.1=No BRIDG mapping (BRIDG has a description, but not a name)
• ResearchStudy.objective.type: BRIDG5.1=StudyObjective.typeCode