Common Data Models Harmonization
1.0.0 - STU 1 Publication

Common Data Models Harmonization, published by HL7 International - Biomedical Research and Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/cdmh/ and changes regularly. See the Directory of published versions

Resource Profile: CdmhResearchStudy - Mappings

Mappings for the cdmh-researchstudy resource profile.

Mappings for BRIDG 5.1 Mapping (https://bridgmodel.nci.nih.gov)

CdmhResearchStudy
ResearchStudyObservationalStudyProtocolVersion; Study; StudyProtocolVersion
   identifierNo BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
   titleNo BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
   protocolStudyProtocolDocumentVersionPublicTitle.name
   partOfCompanionStudyRelationship
   statusStudyOverallStatus.code
   primaryPurposeTypeStudyProtocolVersion.primaryPurposeTypeCode
   phaseStudyProtocolVersion.phaseCode
   categoryInterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
   focusInterventionalStudyProtocol.interventionTypeCode
   conditionStudyCondition.code
   contactPointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
   relatedArtifactStudyProtocolDocument, StudyProtocolDocumentVersion
   keywordDocumentVersion.keywordCode; DocumentVersion.keywordText
   locationStudyProtocolVersion.participatingLocationCode
   descriptionStudyProtocolDocumentVersion.publicDescription
   enrollmentInterventionalStudyProtocol.interventionGroupQuantity
   periodProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
   sponsorRegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
   principalInvestigatorStudyInvestigator
   sitePlannedStudySite; StudySite
   reasonStoppedStudyOverallStatus.studyStoppedReasonCode
   noteNo BRIDG mapping
   armArm
      nameArm.name
      typeArm.typeCode
      descriptionArm.description
   objectiveStudyObjective
      nameNo BRIDG mapping (BRIDG has a description, but not a name)
      typeStudyObjective.typeCode

Mappings for HL7 v2 Mapping (http://hl7.org/v2)

CdmhResearchStudy
ResearchStudyOBX

Mappings for RIM Mapping (http://hl7.org/v3)

CdmhResearchStudy
ResearchStudyEntity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifier.identifier
   protocol.outboundRelationship[typeCode=DEFN].target
   partOf.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
   status.status
   enrollment.participation[typeCode=SBJ].role
   period.effectiveTime
   sponsor.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
   note.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
   arm
      idn/a
      extensionn/a
      modifierExtensionN/A
   objective
      idn/a
      extensionn/a
      modifierExtensionN/A

Mappings for ClinicalTrials.gov Mapping (http://clinicaltrials.gov)

CdmhResearchStudy
ResearchStudy
   identifierOrganization's Unique Protocol ID; Secondary IDs
   titleBrief Title
   protocolInterventions; Arm/Intervention Cross-Reference
   phaseStudy Phase
   categoryStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
   focusFocus of Study
   conditionConditions
   contactCentral Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
   relatedArtifactCitations, Links, Available Study Data/Documents
   keywordKeywords
   descriptionDetailed Description
   enrollmentEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
   periodStudy Start Date (start); Study Completion Date (end)
   sponsorSponsor
   principalInvestigatorPrincipal Investigator
   siteFacility
   reasonStoppedWhy Study Stopped
   armArms
      nameArm Label
      typeArm Type
      descriptionArm Description

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

CdmhResearchStudy
ResearchStudy
   identifierFiveWs.identifier
   statusFiveWs.status
   focusFiveWs.what[x]
   conditionFiveWs.what[x]
   enrollmentFiveWs.subject[x], FiveWs.subject
   periodFiveWs.done[x]
   sponsorFiveWs.actor
   principalInvestigatorFiveWs.actor
   siteFiveWs.where[x]
   reasonStoppedFiveWs.why[x]