Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - 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 Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Business Compartments: Practitioner

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 )

ResearchStudy
    identifierFiveWs.identifier
    statusFiveWs.status
        productCodeFiveWs.what[x]
    conditionFiveWs.what[x]
    periodFiveWs.done[x]
    sponsorFiveWs.actor
    principalInvestigatorFiveWs.actor
    siteFiveWs.where[x]
    whyStoppedFiveWs.why[x]
    recruitmentFiveWs.subject[x]
        actualGroupFiveWs.subject[x]

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

ResearchStudyOBX
    url
    identifier
    version
    name
    title
    label
        type
        value
    protocol
    partOf
    relatedArtifact
    date
    status
    primaryPurposeType
    phase
    category
    focus
        productCode
        focusType
        factor
    condition
    keyword
    location
    descriptionSummary
    description
    period
    contact
    sponsor
    principalInvestigator
    site
    note
    classification
        type
        classifier
    associatedParty
        name
        role
        classifier
        party
    currentState
    statusDate
        activity
        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
        type
        url

8.22.8.3 RIM Mapping (http://hl7.org/v3 )

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

8.22.8.4 ClinicalTrials.gov Mapping (http://clinicaltrials.gov )

ResearchStudy
    url
    identifierOrganization's Unique Protocol ID; Secondary IDs
    version
    name
    titleBrief Title
    label
        type
        value
    protocolInterventions; Arm/Intervention Cross-Reference
    partOf
    relatedArtifactCitations, Links, Available Study Data/Documents
    date
    status
    primaryPurposeType
    phaseStudy Phase
    categoryStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focus
        productCodeFocus of Study
        focusType
        factor
    conditionConditions
    keywordKeywords
    location
    descriptionSummary
    descriptionDetailed Description
    periodStudy Start Date (start); Study Completion Date (end)
    contactCentral Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
    sponsorSponsor
    principalInvestigatorPrincipal Investigator
    siteFacility
    note
    classification
        type
        classifier
    associatedParty
        name
        role
        classifier
        party
    currentState
    statusDate
        activity
        actual
        period
    whyStoppedWhy Study Stopped
    recruitmentEnrollment; 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
        actualGroupEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    comparisonGroupArms
        identifier[x]
        nameArm Label
        typeArm Type
        descriptionArm Description
        intendedExposure
        observedGroup
    objective
        name
        type
        description
    outcomeMeasure
        name
        type
        description
        reference
    result
    webLocation
        type
        url

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

ResearchStudyObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
    url
    identifierNo BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
    version
    name
    titleNo 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
    protocolStudyProtocolDocumentVersionPublicTitle.name
    partOfCompanionStudyRelationship
    relatedArtifactStudyProtocolDocument, StudyProtocolDocumentVersion
    date
    statusStudyOverallStatus.code
    primaryPurposeTypeStudyProtocolVersion.primaryPurposeTypeCode
    phaseStudyProtocolVersion.phaseCode
    categoryInterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focus
        productCodeInterventionalStudyProtocol.interventionTypeCode
        focusType
        factor
    conditionStudyCondition.code
    keywordDocumentVersion.keywordCode; DocumentVersion.keywordText
    locationStudyProtocolVersion.participatingLocationCode
    descriptionSummary
    descriptionStudyProtocolDocumentVersion.publicDescription
    periodProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    contactPointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
    sponsorRegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
    principalInvestigatorStudyInvestigator
    sitePlannedStudySite; StudySite
    noteNo BRIDG mapping
    classification
        type
        classifier
    associatedParty
        name
        role
        classifier
        party
    currentState
    statusDate
        activity
        actual
        period
    whyStoppedStudyOverallStatus.studyStoppedReasonCode
    recruitmentInterventionalStudyProtocol.interventionGroupQuantity
        targetNumber
        actualNumber
        eligibility
        actualGroupInterventionalStudyProtocol.interventionGroupQuantity
    comparisonGroupArm
        identifier[x]
        nameArm.name
        typeArm.typeCode
        descriptionArm.description
        intendedExposure
        observedGroup
    objectiveStudyObjective
        nameNo BRIDG mapping (BRIDG has a description, but not a name)
        typeStudyObjective.typeCode
        description
    outcomeMeasure
        name
        type
        description
        reference
    result
    webLocation
        type
        url