Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

Resource Profile: M11ResearchStudy - Mappings

Page standards status: Draft Maturity Level: 1

Mappings for the m11-research-study resource profile.

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

M11ResearchStudy
ResearchStudyclinical.diagnostics
   identifierFiveWs.identifier
   statusFiveWs.status
   conditionFiveWs.what[x]
   periodFiveWs.done[x]
   siteFiveWs.where[x]
   whyStoppedFiveWs.why[x]
   recruitmentFiveWs.subject[x]
      actualGroupFiveWs.subject[x]

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

M11ResearchStudy
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
   relatedArtifactStudyProtocolDocument, StudyProtocolDocumentVersion
   statusStudyOverallStatus.code
   primaryPurposeTypeStudyProtocolVersion.primaryPurposeTypeCode
   phaseStudyProtocolVersion.phaseCode
   studyDesignInterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
   conditionStudyCondition.code
   keywordDocumentVersion.keywordCode; DocumentVersion.keywordText
   regionStudyProtocolVersion.participatingLocationCode
   descriptionStudyProtocolDocumentVersion.publicDescription
   periodProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
   sitePlannedStudySite; StudySite
   noteNo BRIDG mapping
   whyStoppedStudyOverallStatus.studyStoppedReasonCode
   recruitmentInterventionalStudyProtocol.interventionGroupQuantity
      actualGroupInterventionalStudyProtocol.interventionGroupQuantity
   comparisonGroupArm
      nameArm.name
      typeArm.typeCode
      descriptionArm.description
   objectiveStudyObjective
      nameNo BRIDG mapping (BRIDG has a description, but not a name)
      typeStudyObjective.typeCode

Mappings for HL7 V2 Mapping (http://hl7.org/v2)

M11ResearchStudy
ResearchStudyOBX

Mappings for RIM Mapping (http://hl7.org/v3)

M11ResearchStudy
ResearchStudyEntity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]
   textAct.text?
   containedN/A
   modifierExtensionN/A
   identifier.identifier
   label
      idn/a
      extensionn/a
      modifierExtensionN/A
   protocol.outboundRelationship[typeCode=DEFN].target
   partOf.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
   status.status
   period.effectiveTime
   note.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
   associatedParty
      idn/a
      extensionn/a
      modifierExtensionN/A
   progressStatus
      idn/a
      extensionn/a
      modifierExtensionN/A
   recruitment.participation[typeCode=SBJ].role
      idn/a
      extensionn/a
      modifierExtensionN/A
      actualGroup.participation[typeCode=SBJ].role
   comparisonGroup
      idn/a
      modifierExtensionN/A
   objective
      idn/a
      modifierExtensionN/A
   outcomeMeasure
      idn/a
      extensionn/a
      modifierExtensionN/A

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

M11ResearchStudy
ResearchStudy
   identifierOrganization's Unique Protocol ID; Secondary IDs
   titleBrief Title
   protocolInterventions; Arm/Intervention Cross-Reference
   relatedArtifactCitations, Links, Available Study Data/Documents
   phaseStudy Phase
   studyDesignStudy Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
   conditionConditions
   keywordKeywords
   descriptionDetailed Description
   periodStudy Start Date (start); Study Completion Date (end)
   siteFacility
   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)
      actualGroupEnrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
   comparisonGroupArms
      nameArm Label
      typeArm Type
      descriptionArm Description