FHIR Release 3 (STU) CI-Build

This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 5.0.0 . For a full list Continuous Integration Build of available versions, see FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions icon . Page versions: R5 R4B R4 R3

8.22.6 8.23.8 Resource ResearchStudy - Mappings

Maturity Level : N/A
Responsible Owner: Regulated Clinical Biomedical Research Information Management and Regulation icon Work Group Ballot Standards Status : Informative Security Category : Business Compartments : Practitioner Group

Mappings:

RIM FiveWs Pattern Mapping

HL7 v2 V2 Mapping

RIM Mapping

ClinicalTrials.gov Mapping

BRIDG 5.1 Mapping

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

8.22.6.1 8.23.8.1 Mappings for RIM FiveWs Pattern Mapping (http://hl7.org/v3) ( 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
        actualGroup FiveWs.subject

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

The mappings provided in this tab are indicative of how HL7 v2 fields relate to HL7 FHIR attributes in this resource, but is not complete and without critical HL7 v2 context. The HL7 v2-FHIR Implementation guide, located here icon , provides additional guidance on transforming an HL7 v2 message to FHIR resources for FHIR R4 and FHIR R6.
8.22.6.2 Mappings for HL7 v2 Mapping (http://hl7.org/v2) ResearchStudy
ResearchStudy OBX
Observation[classCode=CLNTRL, moodCode=EVN]     url
    identifier
    version
    name .identifier
    title
    label
        type
        value
        language
    protocol .outboundRelationship[typeCode=DEFN].target
    partOf
    citeAs
    relatesTo
        type
        target[x]
    date .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
    status .status
    category     primaryPurposeType
    focus     phase
    contact     studyDesign
    relatedArtifact     focus
    condition
    keyword
    jurisdiction     region
    description     descriptionSummary
    enrollment     description
    period
    sponsor     site
    principalInvestigator     note
    site     classifier
    reasonStopped     associatedParty
    note         name
    arm         role
        name         period
        code         classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped
    recruitment
        targetNumber
        actualNumber
        eligibility
        actualGroup
        description
    comparisonGroup
        targetNumber
        actualNumber
        eligibility
        observedGroup
OBX         description
    identifier     objective
    title         name
    protocol         type
    partOf         description
    status         outcomeMeasure
    category             name
    focus             type
    contact             description
    relatedArtifact             endpoint
    keyword             population
    jurisdiction             intervention
    description             comparator
    enrollment             summaryMeasure
    period             endpointAnalysisPlan
    sponsor             eventHandling
    principalInvestigator                 event
    site                 group
    reasonStopped                 handling
    note                 description
    arm     result

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

        name ResearchStudy Observation[classCode=CLNTRL, moodCode=EVN]
    identifier .identifier
        code     protocol .outboundRelationship[typeCode=DEFN].target
    partOf .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
        description     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

8.22.6.3 8.23.8.4 Mappings for ClinicalTrials.gov Mapping (http://clinicaltrials.gov) ( http://clinicaltrials.gov icon )

ResearchStudy
    identifier     url
    identifier Organization's Unique Protocol ID; Secondary IDs
    title     version
    name
    title Brief Title
    protocol     label
        type
        value
        language
    protocol Interventions; Arm/Intervention Cross-Reference
    partOf
    citeAs
    relatesTo
        type
        target[x]
    date
    status
    category     primaryPurposeType
    phase Study Phase
    studyDesign Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focus
    condition Conditions or Focus of Study
    contact     keyword Keywords
    region
    descriptionSummary
    description Detailed Description
    period Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Start Date (start); Study tied to only one location); Investigators Completion Date (end)
    relatedArtifact     site Facility
Citations, Links, Available Study Data/Documents     note
    keyword     classifier
Keywords     associatedParty
    jurisdiction         name
    description         role
Detailed         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)
    enrollment         targetNumber
        actualNumber
        eligibility
        actualGroup Enrollment; Number of Groups/Cohorts (= number of "enrollment" "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    period         description
Study Start Date (start); Study Completion Date (end)     comparisonGroup Arms
    sponsor         targetNumber
Sponsor         actualNumber
    principalInvestigator         eligibility
Principal Investigator         observedGroup
    site         description
Facility     objective
    reasonStopped         name
Why Study Stopped         type
    note         description
    arm         outcomeMeasure
Arms             name
            type
            description
            endpoint
            population
            intervention
            comparator
            summaryMeasure
            endpointAnalysisPlan
            eventHandling
                event
                group
                handling
                description
    result

8.23.8.5 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
        language
    protocol StudyProtocolDocumentVersionPublicTitle.name
    partOf CompanionStudyRelationship
    citeAs
    relatesTo
        type
        target[x]
    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
Arm Label         role
        code         period
Arm Type         classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped StudyOverallStatus.studyStoppedReasonCode
    recruitment InterventionalStudyProtocol.interventionGroupQuantity
        targetNumber
        actualNumber
        eligibility
        actualGroup InterventionalStudyProtocol.interventionGroupQuantity
        description
    comparisonGroup Arm Description
        targetNumber
        actualNumber
        eligibility
        observedGroup
        description
    objective StudyObjective
        name No BRIDG mapping (BRIDG has a description, but not a name)
        type StudyObjective.typeCode
        description
        outcomeMeasure
            name
            type
            description
            endpoint
            population
            intervention
            comparator
            summaryMeasure
            endpointAnalysisPlan
            eventHandling
                event
                group
                handling
                description
    result