Release 4B 5

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0: R5 - STU ). The This is the current published version which supercedes in it's permanent home (it will always be available at this version is 5.0.0 . URL). For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R5 R4B R4 R3

8.22.8 8.24.8 Resource ResearchStudy - Mappings

Biomedical Research and Regulation icon Work Group Maturity Level : N/A Standards Status : Informative Security Category : Business Compartments : Practitioner No defined compartments

Mappings:

FiveWs Pattern Mapping

HL7 v2 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).

8.22.8.1 8.24.8.1 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[x]
    reasonStopped         actualGroup FiveWs.why[x] FiveWs.subject[x]

8.22.8.2 8.24.8.2 HL7 v2 V2 Mapping ( http://hl7.org/v2 icon )

ResearchStudy OBX
    url
    identifier
    version
    name
    title
    label
        type
        value
    protocol
    partOf
    relatedArtifact
    date
    status
    primaryPurposeType
    phase
    category     studyDesign
    focus
    condition
    contact     keyword
    relatedArtifact     region
    keyword     descriptionSummary
    location     description
    description     period
    enrollment     site
    period     note
    sponsor     classifier
    principalInvestigator     associatedParty
    site         name
    reasonStopped         role
    note         period
    arm         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

8.22.8.3 8.24.8.3 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

8.22.8.4 8.24.8.4 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
    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 Citations, Links, Available Study Data/Documents Facility
    keyword     note Keywords
    location     classifier
    description     associatedParty Detailed
        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)
    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     comparisonGroup Study Start Date (start); Study Completion Date (end) Arms
    sponsor         linkId Sponsor
    principalInvestigator         name Principal Investigator Arm Label
    site         type Facility Arm Type
    reasonStopped         description Why Study Stopped Arm Description
    note         intendedExposure
    arm         observedGroup Arms
    objective
        name Arm Label
        type Arm Type
        description Arm Description
    objective     outcomeMeasure
        name
        type
        description
        reference
    result

8.22.8.5 8.24.8.5 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
    category     studyDesign InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focus InterventionalStudyProtocol.interventionTypeCode
    condition StudyCondition.code
    contact     keyword PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion DocumentVersion.keywordCode; DocumentVersion.keywordText
    relatedArtifact     region StudyProtocolDocument, StudyProtocolDocumentVersion StudyProtocolVersion.participatingLocationCode
    keyword     descriptionSummary DocumentVersion.keywordCode; DocumentVersion.keywordText
    location     description StudyProtocolVersion.participatingLocationCode StudyProtocolDocumentVersion.publicDescription
    description     period StudyProtocolDocumentVersion.publicDescription ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    enrollment     site InterventionalStudyProtocol.interventionGroupQuantity PlannedStudySite; StudySite
    period     note ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration No BRIDG mapping
    sponsor     classifier RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
    principalInvestigator     associatedParty StudyInvestigator
    site         name PlannedStudySite; StudySite
    reasonStopped         role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped StudyOverallStatus.studyStoppedReasonCode
    note     recruitment No BRIDG mapping InterventionalStudyProtocol.interventionGroupQuantity
    arm         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