Release 4 5 Preview #1

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8.22.7 8.22.8 Resource ResearchStudy - Mappings

Biomedical Research and Regulation Work Group Maturity Level : N/A Standards Status : Informative Security Category : Business Compartments : Practitioner

Mappings:

FiveWs Pattern Mapping

HL7 v2 Mapping

RIM Mapping

ClinicalTrials.gov Mapping

BRIDG 5.1 Mapping

Mappings for the researchstudy resource (see Mappings to Other Standards for further information & status).

8.22.7.1 8.22.8.1 FiveWs Pattern Mapping ( http://hl7.org/fhir/fivews )

ResearchStudy
    identifier FiveWs.identifier
    status FiveWs.status
    focus FiveWs.what[x]
    condition FiveWs.what[x]
    enrollment FiveWs.subject[x]
    period FiveWs.done[x]
    sponsor FiveWs.actor
    principalInvestigator FiveWs.actor
    site FiveWs.where[x]
    reasonStopped FiveWs.why[x]

8.22.7.2 8.22.8.2 HL7 v2 Mapping ( http://hl7.org/v2 )

ResearchStudy OBX
    identifier
    title
    protocol
    partOf
    status
    primaryPurposeType
    phase
    category
    focus
    condition
    contact
    relatedArtifact
    keyword
    location
    description
    enrollment
    period
    sponsor
    principalInvestigator
    site
    reasonStopped
    note
    arm
        name
        type
        description
    objective
        name
        type

8.22.7.3 8.22.8.3 RIM Mapping ( http://hl7.org/v3 )

ResearchStudy Observation[classCode=CLNTRL, moodCode=EVN]
    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]

8.22.7.4 8.22.8.4 ClinicalTrials.gov Mapping ( http://clinicaltrials.gov )

ResearchStudy
    identifier Organization's Unique Protocol ID; Secondary IDs
    title Brief Title
    protocol Interventions; Arm/Intervention Cross-Reference
    partOf
    status
    primaryPurposeType
    phase Study Phase
    category Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focus Focus of Study
    condition Conditions
    contact Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
    relatedArtifact Citations, Links, Available Study Data/Documents
    keyword Keywords
    location
    description Detailed Description
    enrollment Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    period Study Start Date (start); Study Completion Date (end)
    sponsor Sponsor
    principalInvestigator Principal Investigator
    site Facility
    reasonStopped Why Study Stopped
    note
    arm Arms
        name Arm Label
        type Arm Type
        description Arm Description
    objective
        name
        type

8.22.7.5 8.22.8.5 BRIDG 5.1 Mapping ( https://bridgmodel.nci.nih.gov )

ResearchStudy ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
    identifier No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
    title No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
    protocol StudyProtocolDocumentVersionPublicTitle.name
    partOf CompanionStudyRelationship
    status StudyOverallStatus.code
    primaryPurposeType StudyProtocolVersion.primaryPurposeTypeCode
    phase StudyProtocolVersion.phaseCode
    category InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focus InterventionalStudyProtocol.interventionTypeCode
    condition StudyCondition.code
    contact PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
    relatedArtifact StudyProtocolDocument, StudyProtocolDocumentVersion
    keyword DocumentVersion.keywordCode; DocumentVersion.keywordText
    location StudyProtocolVersion.participatingLocationCode
    description StudyProtocolDocumentVersion.publicDescription
    enrollment InterventionalStudyProtocol.interventionGroupQuantity
    period ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    sponsor RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
    principalInvestigator StudyInvestigator
    site PlannedStudySite; StudySite
    reasonStopped StudyOverallStatus.studyStoppedReasonCode
    note No BRIDG mapping
    arm Arm
        name Arm.name
        type Arm.typeCode
        description Arm.description
    objective StudyObjective
        name No BRIDG mapping (BRIDG has a description, but not a name)
        type StudyObjective.typeCode