R6 Ballot (2nd Draft)

This page is part of the FHIR Specification v6.0.0-ballot2: Release 6 Ballot (2nd Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

8.25.8 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).

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

ResearchStudy clinical.diagnostics
    identifier FiveWs.identifier
    status FiveWs.status
    condition FiveWs.what[x]
    period FiveWs.done[x]
    site FiveWs.where[x]
    whyStopped FiveWs.why[x]
    recruitment FiveWs.subject[x]
        actualGroup FiveWs.subject[x]

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

ResearchStudy OBX
    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

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

ResearchStudy Observation[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

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

ResearchStudy
    url
    identifier Organization's Unique Protocol ID; Secondary IDs
    version
    name
    title Brief Title
    label
        type
        value
    protocol Interventions; Arm/Intervention Cross-Reference
    partOf
    relatedArtifact Citations, Links, Available Study Data/Documents
    date
    status
    primaryPurposeType
    phase Study Phase
    studyDesign Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focus
    condition Conditions
    keyword Keywords
    region
    descriptionSummary
    description Detailed Description
    period Study Start Date (start); Study Completion Date (end)
    site Facility
    note
    classifier
    associatedParty
        name
        role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped Why Study Stopped
    recruitment Enrollment; 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
        actualGroup Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    comparisonGroup Arms
        linkId
        name Arm Label
        type Arm Type
        description Arm Description
        intendedExposure
        observedGroup
    objective
        name
        type
        description
    outcomeMeasure
        name
        type
        description
        reference
    result

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

ResearchStudy ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
    url
    identifier No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
    version
    name
    title No 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
    protocol StudyProtocolDocumentVersionPublicTitle.name
    partOf CompanionStudyRelationship
    relatedArtifact StudyProtocolDocument, StudyProtocolDocumentVersion
    date
    status StudyOverallStatus.code
    primaryPurposeType StudyProtocolVersion.primaryPurposeTypeCode
    phase StudyProtocolVersion.phaseCode
    studyDesign InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focus
    condition StudyCondition.code
    keyword DocumentVersion.keywordCode; DocumentVersion.keywordText
    region StudyProtocolVersion.participatingLocationCode
    descriptionSummary
    description StudyProtocolDocumentVersion.publicDescription
    period ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    site PlannedStudySite; StudySite
    note No BRIDG mapping
    classifier
    associatedParty
        name
        role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped StudyOverallStatus.studyStoppedReasonCode
    recruitment InterventionalStudyProtocol.interventionGroupQuantity
        targetNumber
        actualNumber
        eligibility
        actualGroup InterventionalStudyProtocol.interventionGroupQuantity
    comparisonGroup Arm
        linkId
        name Arm.name
        type Arm.typeCode
        description Arm.description
        intendedExposure
        observedGroup
    objective StudyObjective
        name No BRIDG mapping (BRIDG has a description, but not a name)
        type StudyObjective.typeCode
        description
    outcomeMeasure
        name
        type
        description
        reference
    result