Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.3.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: ECLAIREResearchStudy - Mappings

Draft as of 2024-02-26

Mappings for the eclaire-researchstudy resource profile.

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

ECLAIREResearchStudy
ResearchStudy	ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
identifier	No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
identifier (idPrimary)	No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
identifier (idSecondary)	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
status	StudyOverallStatus.code
primaryPurposeType	StudyProtocolVersion.primaryPurposeTypeCode
phase	StudyProtocolVersion.phaseCode
category	InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
focus	InterventionalStudyProtocol.interventionTypeCode
condition	StudyCondition.code
condition (medDRACondition)	StudyCondition.code
condition (diseaseCondition)	StudyCondition.code
contact	PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
relatedArtifact	StudyProtocolDocument, StudyProtocolDocumentVersion
keyword	DocumentVersion.keywordCode; DocumentVersion.keywordText
location	StudyProtocolVersion.participatingLocationCode
description	StudyProtocolDocumentVersion.publicDescription
enrollment	InterventionalStudyProtocol.interventionGroupQuantity
period	ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
site	PlannedStudySite; StudySite
reasonStopped	StudyOverallStatus.studyStoppedReasonCode
note	No BRIDG mapping
arm	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)

ECLAIREResearchStudy
ResearchStudy	OBX
identifier	CX / EI (occasionally, more often EI maps to a resource id or a URL)
identifier (idPrimary)	CX / EI (occasionally, more often EI maps to a resource id or a URL)
use	N/A
type	CE/CNE/CWE, CX.5
system	CX.4 / EI-2-4
value	CX.1 / EI.1
period	DR, CX.7 + CX.8
start	DR.1
end	DR.2
assigner	CX.4 / (CX.4,CX.9,CX.10)
identifier (idSecondary)	CX / EI (occasionally, more often EI maps to a resource id or a URL)
use	N/A
type	CE/CNE/CWE, CX.5
system	CX.4 / EI-2-4
value	CX.1 / EI.1
period	DR, CX.7 + CX.8
assigner	CX.4 / (CX.4,CX.9,CX.10)
primaryPurposeType	CE/CNE/CWE
phase	CE/CNE/CWE
category	CE/CNE/CWE
focus	CE/CNE/CWE
condition	CE/CNE/CWE
condition (medDRACondition)	CE/CNE/CWE
coding	CE/CNE/CWE subset one of the sets of component 1-3 or 4-6, C*E.1-8, C*E.10-22
system	C*E.3
version	C*E.7
code	C*E.1
display	C*E.2 - but note this is not well followed
userSelected	Sometimes implied by being first
text	C*E.9. But note many systems use C*E.2 for this
condition (diseaseCondition)	CE/CNE/CWE
coding	CE/CNE/CWE subset one of the sets of component 1-3 or 4-6, C*E.1-8, C*E.10-22
text	C*E.9. But note many systems use C*E.2 for this
contact
telecom	XTN
keyword	CE/CNE/CWE
location	CE/CNE/CWE
period	DR
start	DR.1
end	DR.2
reasonStopped	CE/CNE/CWE
note	N/A
arm
type	CE/CNE/CWE
objective
type	CE/CNE/CWE

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

ECLAIREResearchStudy
ResearchStudy	Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
meta	n/a, N/A
implicitRules	n/a
language	n/a
text	n/a, N/A, Act.text?
contained	Entity. Role, or Act, N/A
extension	n/a, N/A
extension (eclaire-review-date)
extension (eclaire-approval-date)
extension (eclaire-therapeutic-area)
extension (eclaire-recruitment-period)
extension (eclaire-recruitment-status)
extension (eclaire-description-summary-r5)	n/a, N/A
id	n/a
url	N/A
value[x]	n/a, N/A
modifierExtension	n/a, N/A
identifier	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
identifier (idPrimary)	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
id	n/a
extension	n/a, N/A
use	n/a, Role.code or implied by context
type	n/a, CD, Role.code or implied by context
system	n/a, II.root or Role.id.root
value	n/a, II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"], Role.effectiveTime or implied by context
id	n/a
extension	n/a, N/A
start	n/a, ./low
end	n/a, ./high
assigner	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
identifier (idSecondary)	n/a, II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT], .identifier
id	n/a
extension	n/a, N/A
use	n/a, Role.code or implied by context
type	n/a, CD, Role.code or implied by context
system	n/a, II.root or Role.id.root
value	n/a, II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"], Role.effectiveTime or implied by context
assigner	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
title	n/a
protocol	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .outboundRelationship[typeCode=DEFN].target
partOf	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	n/a, .status
primaryPurposeType	n/a, CD
phase	n/a, CD
category	n/a, CD
focus	n/a, CD
condition	n/a, CD
condition (medDRACondition)	n/a, CD
id	n/a
extension	n/a, N/A
coding	n/a, CV, union(., ./translation)
id	n/a
extension	n/a, N/A
system	n/a, ./codeSystem
version	n/a, ./codeSystemVersion
code	n/a, ./code
display	n/a, CV.displayName
userSelected	n/a, CD.codingRationale
text	n/a, ./originalText[mediaType/code="text/plain"]/data
condition (diseaseCondition)	n/a, CD
id	n/a
extension	n/a, N/A
coding	n/a, CV, union(., ./translation)
text	n/a, ./originalText[mediaType/code="text/plain"]/data
contact	n/a
id	n/a
extension	n/a, N/A
name	n/a
telecom	n/a, TEL
relatedArtifact	n/a
keyword	n/a, CD
location	n/a, CD
description	n/a
enrollment	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity), .participation[typeCode=SBJ].role
period	n/a, IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"], .effectiveTime
id	n/a
extension	n/a, N/A
start	n/a, ./low
end	n/a, ./high
site	n/a, The target of a resource reference is a RIM entry point (Act, Role, or Entity)
reasonStopped	n/a, CD
note	n/a, Act, .inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
arm	n/a
id	n/a
extension	n/a, N/A
modifierExtension	n/a, N/A
name	n/a
type	n/a, CD
description	n/a
objective	n/a
id	n/a
extension	n/a, N/A
modifierExtension	n/a, N/A
name	n/a
type	n/a, CD

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

ECLAIREResearchStudy
ResearchStudy
identifier	Organization's Unique Protocol ID; Secondary IDs
identifier (idPrimary)	Organization's Unique Protocol ID; Secondary IDs
identifier (idSecondary)	Organization's Unique Protocol ID; Secondary IDs
title	Brief Title
protocol	Interventions; Arm/Intervention Cross-Reference
phase	Study Phase
category	Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
focus	Focus of Study
condition	Conditions
condition (medDRACondition)	Conditions
condition (diseaseCondition)	Conditions
contact	Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
relatedArtifact	Citations, Links, Available Study Data/Documents
keyword	Keywords
description	Detailed Description
enrollment	Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
period	Study Start Date (start); Study Completion Date (end)
site	Facility
reasonStopped	Why Study Stopped
arm	Arms
name	Arm Label
type	Arm Type
description	Arm Description

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

ECLAIREResearchStudy
ResearchStudy
identifier	FiveWs.identifier
identifier (idPrimary)	FiveWs.identifier
identifier (idSecondary)	FiveWs.identifier
status	FiveWs.status
focus	FiveWs.what[x]
condition	FiveWs.what[x]
condition (medDRACondition)	FiveWs.what[x]
condition (diseaseCondition)	FiveWs.what[x]
enrollment	FiveWs.subject[x], FiveWs.subject
period	FiveWs.done[x]
site	FiveWs.where[x]
reasonStopped	FiveWs.why[x]