R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). 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

8.25.7 Resource ResearchStudy - Mappings

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: Informative Compartments: Practitioner

Mappings:

FiveWs Pattern

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).

8.25.7.1 Mappings for FiveWs Pattern (http://hl7.org/fhir/fivews )

ResearchStudy
    identifierFiveWs.identifier
    statusFiveWs.status
    focusFiveWs.what[x]
    conditionFiveWs.what[x]
    enrollmentFiveWs.subject[x]
    periodFiveWs.done[x]
    sponsorFiveWs.actor
    principalInvestigatorFiveWs.actor
    siteFiveWs.where[x]
    reasonStoppedFiveWs.why[x]

8.25.7.2 Mappings for HL7 v2 Mapping (http://hl7.org/v2)

ResearchStudyOBX
    identifier
    title
    protocol
    partOf
    status
    primaryPurposeType
    phase
    category
    focus
    condition
    contact
    relatedArtifact
    keyword
    location
    description
    enrollment
    period
    sponsor
    principalInvestigator
    site
    reasonStopped
    note
    arm
        name
        type
        description
    objective
        name
        type

8.25.7.3 Mappings for 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
    enrollment.participation[typeCode=SBJ].role
    period.effectiveTime
    sponsor.participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]
    note.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]

8.25.7.4 Mappings for ClinicalTrials.gov Mapping (http://clinicaltrials.gov )

ResearchStudy
    identifierOrganization's Unique Protocol ID; Secondary IDs
    titleBrief Title
    protocolInterventions; Arm/Intervention Cross-Reference
    partOf
    status
    primaryPurposeType
    phaseStudy Phase
    categoryStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
    focusFocus of Study
    conditionConditions
    contactCentral Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
    relatedArtifactCitations, Links, Available Study Data/Documents
    keywordKeywords
    location
    descriptionDetailed Description
    enrollmentEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
    periodStudy Start Date (start); Study Completion Date (end)
    sponsorSponsor
    principalInvestigatorPrincipal Investigator
    siteFacility
    reasonStoppedWhy Study Stopped
    note
    armArms
        nameArm Label
        typeArm Type
        descriptionArm Description
    objective
        name
        type

8.25.7.5 Mappings for BRIDG 5.1 Mapping (https://bridgmodel.nci.nih.gov/download-model/bridg-releases/release-51/release-package )

ResearchStudyObservationalStudyProtocolVersion; Study;
StudyProtocolVersion
    identifierNo BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
    titleNo BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
    protocolStudyProtocolDocumentVersionPublicTitle.name
    partOfCompanionStudyRelationship
    statusStudyOverallStatus.code
    primaryPurposeTypeStudyProtocolVersion.primaryPurposeTypeCode
    phaseStudyProtocolVersion.phaseCode
    categoryInterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
    focusInterventionalStudyProtocol.interventionTypeCode
    conditionStudyCondition.code
    contactPointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
    relatedArtifactStudyProtocolDocument, StudyProtocolDocumentVersion
    keywordDocumentVersion.keywordCode; DocumentVersion.keywordText
    locationStudyProtocolVersion.participatingLocationCode
    descriptionStudyProtocolDocumentVersion.publicDescription
    enrollmentInterventionalStudyProtocol.interventionGroupQuantity
    periodProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
    sponsorRegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
    principalInvestigatorStudyInvestigator
    sitePlannedStudySite; StudySite
    reasonStoppedStudyOverallStatus.studyStoppedReasonCode
    noteNo BRIDG mapping
    armArm
        nameArm.name
        typeArm.typeCode
        descriptionArm.description
    objectiveStudyObjective
        nameNo BRIDG mapping (BRIDG has a description, but not a name)
        typeStudyObjective.typeCode