MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

MII Implementation Guide Medizinisches Forschungsvorhaben - Downloaded Version 2027.0.0-ballot See the Directory of published versions

Resource Profile: MII PR Studie Studie - Mappings

Active as of 2026-01-09

Mappings for the mii-pr-studie-studie resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameBRIDG 5.1 MappingHL7 v2 MappingClinicalTrials.gov MappingFiveWs Pattern Mappingdoco
.. ResearchStudy
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
OBX
... id
... meta
... implicitRules
... language
... text
... contained
... Slices for extension
.... extension:Label
.... extension:AssociatedParty
.... extension:Ethikvotum
.... extension:Studienregister
.... extension:Eligibility
.... extension:Akronym
.... extension:Rekrutierung
.... extension:Finanzierung
... modifierExtension
... identifier
  • No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion
  • this is arguably a different semantic)
Organization's Unique Protocol ID; Secondary IDs
FiveWs.identifier
.... id
.... extension
.... use
N/A
.... type
CX.5
.... system
CX.4 / EI-2-4
.... value
CX.1 / EI.1
.... period
CX.7 + CX.8
.... assigner
  • CX.4 / (CX.4
  • CX.9
  • CX.10)
... title
title of a document vs title of a research study)
Brief Title
... protocol
StudyProtocolDocumentVersionPublicTitle.name
Interventions; Arm/Intervention Cross-Reference
... partOf
CompanionStudyRelationship
... status
StudyOverallStatus.code
FiveWs.status
... primaryPurposeType
StudyProtocolVersion.primaryPurposeTypeCode
... phase
StudyProtocolVersion.phaseCode
Study Phase
... category
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
... focus
InterventionalStudyProtocol.interventionTypeCode
Focus of Study
FiveWs.what[x]
.... id
.... extension
.... coding
  • C*E.1-8
  • C*E.10-22
.... text
C*E.9. But note many systems use C*E.2 for this
... condition
StudyCondition.code
Conditions
FiveWs.what[x]
... contact
PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
... relatedArtifact
  • StudyProtocolDocument
  • StudyProtocolDocumentVersion
  • Citations
  • Links
  • Available Study Data/Documents
... keyword
DocumentVersion.keywordCode; DocumentVersion.keywordText
Keywords
.... id
.... extension
.... coding
  • C*E.1-8
  • C*E.10-22
.... text
C*E.9. But note many systems use C*E.2 for this
... location
StudyProtocolVersion.participatingLocationCode
... description
StudyProtocolDocumentVersion.publicDescription
Detailed Description
... enrollment
InterventionalStudyProtocol.interventionGroupQuantity
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
FiveWs.subject
... period
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
Study Start Date (start); Study Completion Date (end)
FiveWs.done[x]
... sponsor
RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
Sponsor
FiveWs.actor
... principalInvestigator
StudyInvestigator
Principal Investigator
FiveWs.actor
... site
PlannedStudySite; StudySite
Facility
FiveWs.where[x]
... reasonStopped
StudyOverallStatus.studyStoppedReasonCode
Why Study Stopped
FiveWs.why[x]
... note
No BRIDG mapping
... arm
Arm
Arms
.... id
.... extension
.... modifierExtension
.... name
Arm.name
Arm Label
.... type
Arm.typeCode
Arm Type
.... description
Arm.description
Arm Description
... objective
StudyObjective
.... id
.... extension
.... modifierExtension
.... name
  • No BRIDG mapping (BRIDG has a description
  • but not a name)
.... type
StudyObjective.typeCode

doco Documentation for this format