NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: NcpiResearchStudy - Mappings

Draft as of 2023-09-15

Mappings for the ncpi-research-study resource profile.

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

NcpiResearchStudy
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
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
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
sponsor	RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
principalInvestigator	StudyInvestigator
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)

NcpiResearchStudy
ResearchStudy	OBX
category
coding	C*E.1-8, C*E.10-22
text	C*E.9. But note many systems use C*E.2 for this

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

NcpiResearchStudy
ResearchStudy	Entity. Role, or Act, Observation[classCode=CLNTRL, moodCode=EVN]
text	Act.text?
contained	N/A
extension	N/A
modifierExtension	N/A
identifier	.identifier
protocol	.outboundRelationship[typeCode=DEFN].target
partOf	.inboundRelationship[typeCode=COMP].source[moodCode=EVN]
status	.status
category
id	n/a
extension	n/a
coding	union(., ./translation)
text	./originalText[mediaType/code="text/plain"]/data
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]
arm
id	n/a
extension	n/a
modifierExtension	N/A
objective
id	n/a
extension	n/a
modifierExtension	N/A

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

NcpiResearchStudy
ResearchStudy
identifier	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
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)
sponsor	Sponsor
principalInvestigator	Principal Investigator
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)

NcpiResearchStudy
ResearchStudy
identifier	FiveWs.identifier
status	FiveWs.status
focus	FiveWs.what[x]
condition	FiveWs.what[x]
enrollment	FiveWs.subject[x], FiveWs.subject
period	FiveWs.done[x]
sponsor	FiveWs.actor
principalInvestigator	FiveWs.actor
site	FiveWs.where[x]
reasonStopped	FiveWs.why[x]