MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: MII PR Studie Proband

Official URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband Version: 2027.0.0-ballot
Active as of 2026-01-09 Computable Name: MII_PR_Studie_Proband

This profile describes a study subject within the Medical Informatics Initiative.

Subject (ResearchSubject)


This profile describes a subject in the Medical Informatics Initiative.


Notes

FHIR Element Explanation
ResearchSubject.id Must-support, but optional
ResearchSubject.meta Must-support, but optional
ResearchSubject.meta.profile MANDATORY for querying in the DIC repository, including the version number of the profile. See CapabilityStatement. Optional in all other cases.
Patient.identifier:subjectIdentificationCode Fixed NamingSystem for the uniform, cross-site querying of the identifier (for analyses)
ResearchSubject.period.start Start date (inclusion of the patient in the study)
ResearchSubject.period.end End date (completion of the study or exclusion of the patient)
ResearchSubject.study Reference to the metadata of the study in which the patient is participating.
ResearchSubject.individual Every subject MUST be assigned to a patient.
ResearchSubject.consent Consent to the study or a regulatory basis MUST be present. Further requirements for the modeling of the consent may arise from other modules.

Mapping

FHIR Element Logical Data Set
ResearchSubject.identifier:subjectIdentificationCode Person.Studienteilnehmer.SubjektIdentifizierungscode
ResearchSubject.status Person.Studienteilnehmer.StatusDerTeilnahme
ResearchSubject.period.start Person.Studienteilnehmer.BeginnTeilnahme
ResearchSubject.period.end Person.Studienteilnehmer.EndeTeilnahme
ResearchSubject.consent Person.Studienteilnehmer.Rechtsgrundlage

Examples

See example (minimal):

ResearchSubject-mii-exa-studie-proband

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id SΣ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for identifier SΣ 1..* Identifier Business Identifier for study subject.
Slice: Unordered, Open by pattern:$this
.... identifier:subjectIdentificationCode SΣ 1..1 Identifier Business Identifier for research subject in a study

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... period 0..1 Period Time period when id is/was valid for use
..... assigner 0..1 Reference(Organization) Organization that issued id (may be just text)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ANON
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 1..1 string The value that is unique
Example General: 123456
... status ?!SΣ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
... period SΣ 1..1 Period Start and end of participation.
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudy) study subject is part of
... individual SΣ 1..1 Reference(Patient) Who is part of study.
... consent S 1..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.identifier:subjectIdentificationCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id S 0..1 id Logical id of this artifact
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for identifier S 1..* Identifier Business Identifier for study subject.
Slice: Unordered, Open by pattern:$this
.... identifier:subjectIdentificationCode S 1..1 Identifier Business Identifier for research subject in a study
Required Pattern: At least the following
..... type S 0..1 CodeableConcept Description of identifier
Fixed Value: (Complex)
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ANON
..... system S 1..1 uri The namespace for the identifier value
..... value S 1..1 string The value that is unique
... period S 1..1 Period Start and end of participation.
.... start S 1..1 dateTime Starting time with inclusive boundary
.... end S 0..1 dateTime End time with inclusive boundary, if not ongoing
... study S 1..1 Reference(ResearchStudy) study subject is part of
... individual S 1..1 Reference(Patient) Who is part of study.
... consent S 1..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id SΣ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier SΣ 1..* Identifier Business Identifier for study subject.
Slice: Unordered, Open by pattern:$this
.... identifier:subjectIdentificationCode SΣ 1..1 Identifier Business Identifier for research subject in a study

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ANON
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... status ?!SΣ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
... period SΣ 1..1 Period Start and end of participation.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudy) study subject is part of
... individual SΣ 1..1 Reference(Patient) Who is part of study.
... assignedArm 0..1 string What path should be followed
... actualArm 0..1 string What path was followed
... consent S 1..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.meta.​security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
ResearchSubject.meta.​tag Base example Common Tags 📍4.0.1 FHIR Std.
ResearchSubject.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 7 elements
Must-Support: 15 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of ResearchSubject.identifier

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id SΣ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for identifier SΣ 1..* Identifier Business Identifier for study subject.
Slice: Unordered, Open by pattern:$this
.... identifier:subjectIdentificationCode SΣ 1..1 Identifier Business Identifier for research subject in a study

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... period 0..1 Period Time period when id is/was valid for use
..... assigner 0..1 Reference(Organization) Organization that issued id (may be just text)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ANON
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 1..1 string The value that is unique
Example General: 123456
... status ?!SΣ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
... period SΣ 1..1 Period Start and end of participation.
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudy) study subject is part of
... individual SΣ 1..1 Reference(Patient) Who is part of study.
... consent S 1..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.identifier:subjectIdentificationCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id S 0..1 id Logical id of this artifact
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for identifier S 1..* Identifier Business Identifier for study subject.
Slice: Unordered, Open by pattern:$this
.... identifier:subjectIdentificationCode S 1..1 Identifier Business Identifier for research subject in a study
Required Pattern: At least the following
..... type S 0..1 CodeableConcept Description of identifier
Fixed Value: (Complex)
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ANON
..... system S 1..1 uri The namespace for the identifier value
..... value S 1..1 string The value that is unique
... period S 1..1 Period Start and end of participation.
.... start S 1..1 dateTime Starting time with inclusive boundary
.... end S 0..1 dateTime End time with inclusive boundary, if not ongoing
... study S 1..1 Reference(ResearchStudy) study subject is part of
... individual S 1..1 Reference(Patient) Who is part of study.
... consent S 1..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Physical entity which is the primary unit of interest in the study
... id SΣ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier SΣ 1..* Identifier Business Identifier for study subject.
Slice: Unordered, Open by pattern:$this
.... identifier:subjectIdentificationCode SΣ 1..1 Identifier Business Identifier for research subject in a study

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type SΣ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: ANON
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system SΣ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value SΣ 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... status ?!SΣ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
... period SΣ 1..1 Period Start and end of participation.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudy) study subject is part of
... individual SΣ 1..1 Reference(Patient) Who is part of study.
... assignedArm 0..1 string What path should be followed
... actualArm 0..1 string What path was followed
... consent S 1..1 Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.meta.​security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
ResearchSubject.meta.​tag Base example Common Tags 📍4.0.1 FHIR Std.
ResearchSubject.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchSubject.status Base required ResearchSubjectStatus 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 7 elements
Must-Support: 15 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of ResearchSubject.identifier

 

Other representations of profile: CSV, Excel, Schematron