R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

8.24.8 Resource ResearchStudy - Mappings

Biomedical Research and Regulation icon Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Business Compartments: No defined compartments

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).

8.24.8.1 FiveWs Pattern Mapping (http://hl7.org/fhir/fivews icon)

ResearchStudyclinical.diagnostics
    identifierFiveWs.identifier
    statusFiveWs.status
    conditionFiveWs.what[x]
    periodFiveWs.done[x]
    siteFiveWs.where[x]
    whyStoppedFiveWs.why[x]
    recruitmentFiveWs.subject[x]
        actualGroupFiveWs.subject[x]

8.24.8.2 HL7 V2 Mapping (http://hl7.org/v2 icon)

ResearchStudyOBX
    url
    identifier
    version
    name
    title
    label
        type
        value
    protocol
    partOf
    relatedArtifact
    date
    status
    primaryPurposeType
    phase
    studyDesign
    focus
    condition
    keyword
    region
    descriptionSummary
    description
    period
    site
    note
    classifier
    associatedParty
        name
        role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped
    recruitment
        targetNumber
        actualNumber
        eligibility
        actualGroup
    comparisonGroup
        linkId
        name
        type
        description
        intendedExposure
        observedGroup
    objective
        name
        type
        description
    outcomeMeasure
        name
        type
        description
        reference
    result

8.24.8.3 RIM Mapping (http://hl7.org/v3 icon)

ResearchStudyObservation[classCode=CLNTRL, moodCode=EVN]
    identifier.identifier
    protocol.outboundRelationship[typeCode=DEFN].target
    partOf.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
    status.status
    period.effectiveTime
    note.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
    recruitment.participation[typeCode=SBJ].role
        actualGroup.participation[typeCode=SBJ].role

8.24.8.4 ClinicalTrials.gov Mapping (http://clinicaltrials.gov icon)

ResearchStudy
    url
    identifierOrganization's Unique Protocol ID; Secondary IDs
    version
    name
    titleBrief Title
    label
        type
        value
    protocolInterventions; Arm/Intervention Cross-Reference
    partOf
    relatedArtifactCitations, Links, Available Study Data/Documents
    date
    status
    primaryPurposeType
    phaseStudy Phase
    studyDesignStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focus
    conditionConditions
    keywordKeywords
    region
    descriptionSummary
    descriptionDetailed Description
    periodStudy Start Date (start); Study Completion Date (end)
    siteFacility
    note
    classifier
    associatedParty
        name
        role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStoppedWhy Study Stopped
    recruitmentEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
        targetNumber
        actualNumber
        eligibility
        actualGroupEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    comparisonGroupArms
        linkId
        nameArm Label
        typeArm Type
        descriptionArm Description
        intendedExposure
        observedGroup
    objective
        name
        type
        description
    outcomeMeasure
        name
        type
        description
        reference
    result

8.24.8.5 BRIDG 5.1 Mapping (https://bridgmodel.nci.nih.gov icon)

ResearchStudyObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
    url
    identifierNo BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
    version
    name
    titleNo BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
    label
        type
        value
    protocolStudyProtocolDocumentVersionPublicTitle.name
    partOfCompanionStudyRelationship
    relatedArtifactStudyProtocolDocument, StudyProtocolDocumentVersion
    date
    statusStudyOverallStatus.code
    primaryPurposeTypeStudyProtocolVersion.primaryPurposeTypeCode
    phaseStudyProtocolVersion.phaseCode
    studyDesignInterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focus
    conditionStudyCondition.code
    keywordDocumentVersion.keywordCode; DocumentVersion.keywordText
    regionStudyProtocolVersion.participatingLocationCode
    descriptionSummary
    descriptionStudyProtocolDocumentVersion.publicDescription
    periodProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    sitePlannedStudySite; StudySite
    noteNo BRIDG mapping
    classifier
    associatedParty
        name
        role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStoppedStudyOverallStatus.studyStoppedReasonCode
    recruitmentInterventionalStudyProtocol.interventionGroupQuantity
        targetNumber
        actualNumber
        eligibility
        actualGroupInterventionalStudyProtocol.interventionGroupQuantity
    comparisonGroupArm
        linkId
        nameArm.name
        typeArm.typeCode
        descriptionArm.description
        intendedExposure
        observedGroup
    objectiveStudyObjective
        nameNo BRIDG mapping (BRIDG has a description, but not a name)
        typeStudyObjective.typeCode
        description
    outcomeMeasure
        name
        type
        description
        reference
    result