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8.22.7 8.23.8 Resource ResearchStudy - Mappings

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

Mappings:

FiveWs Pattern Mapping

HL7 v2 V2 Mapping

RIM Mapping

ClinicalTrials.gov Mapping

BRIDG 5.1 Mapping

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

8.22.7.1 8.23.8.1 FiveWs Pattern Mapping ( http://hl7.org/fhir/fivews icon )

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

8.22.7.2 8.23.8.2 HL7 v2 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.
ResearchStudy OBX
    url
    identifier
    version
    name
    title
    label
    protocol         type
        value
        language
    protocol
    partOf
    citeAs
    status     relatesTo
        type
    primaryPurposeType         target[x]
    date
    phase     status
    primaryPurposeType
    category     phase
    studyDesign
    focus
    condition
    keyword
    contact     region
    descriptionSummary
    relatedArtifact     description
    period
    site
    keyword     note
    classifier
    location     associatedParty
        name
    description         role
        period
    enrollment         classifier
        party
    period     progressStatus
        state
    sponsor         actual
        period
    principalInvestigator     whyStopped
    recruitment
    site         targetNumber
        actualNumber
    reasonStopped         eligibility
        actualGroup
    note         description
    comparisonGroup
        targetNumber
    arm         actualNumber
        eligibility
        name         observedGroup
        description
        type     objective
        name
        type
        description
        outcomeMeasure
    objective             name
            type
        name             description
            endpoint
        type             population
            intervention
            comparator
            summaryMeasure
            endpointAnalysisPlan
            eventHandling
                event
                group
                handling
                description
    result

8.22.7.3 8.23.8.3 RIM Mapping ( http://hl7.org/v3 icon )

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

8.22.7.4 8.23.8.4 ClinicalTrials.gov Mapping ( http://clinicaltrials.gov icon )

ResearchStudy
    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
    status     relatesTo
        type
    primaryPurposeType         target[x]
    date
    phase     status
    primaryPurposeType
    phase Study Phase
    category     studyDesign Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focus Focus of Study
    condition Conditions
    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
    location         name
        role
    description         period
        classifier
Detailed         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" 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
        actualNumber
Sponsor         eligibility
    principalInvestigator         observedGroup
Principal Investigator         description
    site     objective
Facility         name
    reasonStopped         type
Why Study Stopped         description
    note         outcomeMeasure
            name
    arm             type
Arms             description
        name             endpoint
Arm Label             population
        type             intervention
Arm Type             comparator
        description             summaryMeasure
Arm Description             endpointAnalysisPlan
    objective             eventHandling
                event
        name                 group
                handling
        type                 description
    result

8.22.7.5 8.23.8.5 BRIDG 5.1 Mapping ( https://bridgmodel.nci.nih.gov icon )

ResearchStudy ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
    identifier     url
    identifier No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
    title     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)
    protocol     label
        type
        value
        language
    protocol StudyProtocolDocumentVersionPublicTitle.name
    partOf CompanionStudyRelationship
    status     citeAs
    relatesTo
        type
        target[x]
    date
    status StudyOverallStatus.code
    primaryPurposeType StudyProtocolVersion.primaryPurposeTypeCode
    phase StudyProtocolVersion.phaseCode
    category     studyDesign InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focus InterventionalStudyProtocol.interventionTypeCode
    condition StudyCondition.code
    contact     keyword DocumentVersion.keywordCode; DocumentVersion.keywordText
PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion     region StudyProtocolVersion.participatingLocationCode
    relatedArtifact     descriptionSummary
StudyProtocolDocument, StudyProtocolDocumentVersion     description StudyProtocolDocumentVersion.publicDescription
    keyword     period ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
DocumentVersion.keywordCode; DocumentVersion.keywordText     site PlannedStudySite; StudySite
    location     note No BRIDG mapping
StudyProtocolVersion.participatingLocationCode     classifier
    description     associatedParty
StudyProtocolDocumentVersion.publicDescription         name
    enrollment         role
InterventionalStudyProtocol.interventionGroupQuantity         period
    period         classifier
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration         party
    sponsor     progressStatus
RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode         state
    principalInvestigator         actual
StudyInvestigator         period
    site     whyStopped StudyOverallStatus.studyStoppedReasonCode
PlannedStudySite; StudySite     recruitment InterventionalStudyProtocol.interventionGroupQuantity
    reasonStopped         targetNumber
StudyOverallStatus.studyStoppedReasonCode         actualNumber
    note         eligibility
No BRIDG mapping         actualGroup InterventionalStudyProtocol.interventionGroupQuantity
    arm         description
    comparisonGroup Arm
        name         targetNumber
Arm.name         actualNumber
        type         eligibility
Arm.typeCode         observedGroup
        description Arm.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