Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

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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
ResearchStudy	clinical.diagnostics
identifier	FiveWs.identifier
status	FiveWs.status
condition	FiveWs.what[x]
period	FiveWs.done[x]
site	FiveWs.where[x]
whyStopped	FiveWs.why[x]
recruitment	FiveWs.subject[x]
actualGroup	FiveWs.subject[x]

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

M11ResearchStudy
ResearchStudy	ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
identifier	No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
title	No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
protocol	StudyProtocolDocumentVersionPublicTitle.name
partOf	CompanionStudyRelationship
relatedArtifact	StudyProtocolDocument, StudyProtocolDocumentVersion
status	StudyOverallStatus.code
primaryPurposeType	StudyProtocolVersion.primaryPurposeTypeCode
phase	StudyProtocolVersion.phaseCode
studyDesign	InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
condition	StudyCondition.code
keyword	DocumentVersion.keywordCode; DocumentVersion.keywordText
region	StudyProtocolVersion.participatingLocationCode
description	StudyProtocolDocumentVersion.publicDescription
period	ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
site	PlannedStudySite; StudySite
note	No BRIDG mapping
whyStopped	StudyOverallStatus.studyStoppedReasonCode
recruitment	InterventionalStudyProtocol.interventionGroupQuantity
actualGroup	InterventionalStudyProtocol.interventionGroupQuantity
comparisonGroup	Arm
name	Arm.name
type	Arm.typeCode
description	Arm.description
objective	StudyObjective
name	No BRIDG mapping (BRIDG has a description, but not a name)
type	StudyObjective.typeCode

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

M11ResearchStudy
ResearchStudy	OBX

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

M11ResearchStudy
ResearchStudy	Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]
text	Act.text?
contained	N/A
modifierExtension	N/A
identifier	.identifier
label
id	n/a
extension	n/a
modifierExtension	N/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
id	n/a
extension	n/a
modifierExtension	N/A
progressStatus
id	n/a
extension	n/a
modifierExtension	N/A
recruitment	.participation[typeCode=SBJ].role
id	n/a
extension	n/a
modifierExtension	N/A
actualGroup	.participation[typeCode=SBJ].role
comparisonGroup
id	n/a
extension	n/a
modifierExtension	N/A
objective
id	n/a
modifierExtension	N/A
outcomeMeasure
id	n/a
extension	n/a
modifierExtension	N/A

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

M11ResearchStudy
ResearchStudy
identifier	Organization's Unique Protocol ID; Secondary IDs
title	Brief Title
protocol	Interventions; Arm/Intervention Cross-Reference
relatedArtifact	Citations, Links, Available Study Data/Documents
phase	Study Phase
studyDesign	Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
condition	Conditions
keyword	Keywords
description	Detailed Description
period	Study Start Date (start); Study Completion Date (end)
site	Facility
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)
actualGroup	Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
comparisonGroup	Arms
name	Arm Label
type	Arm Type
description	Arm Description