Release 4B 5 Ballot

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-ballot: R5 Ballot - STU see ballot notes ). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.22.8 Resource ResearchStudy - Mappings

Biomedical Research and Regulation icon Work Group Maturity Level : N/A Standards Status : Informative Security Category : Business Compartments : Practitioner Not linked to any 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).

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

ResearchStudy
    identifier FiveWs.identifier
    status FiveWs.status
    focus         productCode 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 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
    category     studyDesign
    focus
    condition         productCode
    contact         focusType
    relatedArtifact         factor
    condition
    keyword
    location     region
    description     descriptionSummary
    enrollment     description
    period
    sponsor     site
    principalInvestigator     note
    site     classifier
    reasonStopped     associatedParty
    note         name
    arm         role
        period
        classifier
        party
    progressStatus
        state
        actual
        period
    whyStopped
    recruitment
        targetNumber
        actualNumber
        eligibility
        actualGroup
    comparisonGroup
        identifier[x]
        name
        type
        description
        intendedExposure
        observedGroup
    objective
        name
        type
        description
    outcomeMeasure
        name
        type
        description
        reference
    result
    webLocation
        classifier
        url

8.22.8.3 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 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
        productCode Focus of Study
    condition         focusType Conditions
    contact         factor Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
    relatedArtifact     condition Citations, Links, Available Study Data/Documents Conditions
    keyword Keywords
    location     region
    descriptionSummary
    description Detailed Description
    enrollment     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)
    period         targetNumber Study Start Date (start); Study Completion Date (end)
    sponsor         actualNumber Sponsor
    principalInvestigator         eligibility Principal Investigator
    site         actualGroup Facility Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    reasonStopped     comparisonGroup Why Study Stopped Arms
    note         identifier[x]
    arm         name Arms Arm Label
        name         type Arm Label Type
        type         description Arm Type Description
        description         intendedExposure Arm Description
        observedGroup
    objective
        name
        type
        description
    outcomeMeasure
        name
        type
        description
        reference
    result
    webLocation
        classifier
        url

8.22.8.5 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
        productCode InterventionalStudyProtocol.interventionTypeCode
    condition         focusType StudyCondition.code
    contact         factor PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
    relatedArtifact     condition StudyProtocolDocument, StudyProtocolDocumentVersion StudyCondition.code
    keyword DocumentVersion.keywordCode; DocumentVersion.keywordText
    location     region StudyProtocolVersion.participatingLocationCode
    description     descriptionSummary StudyProtocolDocumentVersion.publicDescription
    enrollment     description InterventionalStudyProtocol.interventionGroupQuantity StudyProtocolDocumentVersion.publicDescription
    period ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    sponsor     site RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode PlannedStudySite; StudySite
    principalInvestigator     note StudyInvestigator No BRIDG mapping
    site     classifier PlannedStudySite; StudySite
    reasonStopped     associatedParty
        name
        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
        identifier[x]
        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
    webLocation
        classifier
        url