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
| 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.
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):
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots, and their representations.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
![]() ![]() |
SΣ | 0..1 | id | Logical id of this artifact |
![]() ![]() |
SΣ | 0..1 | Meta | Metadata about the resource |
![]() ![]() ![]() |
SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
SΣ | 1..* | Identifier | Business Identifier for study subject. Slice: Unordered, Open by pattern:$this |
![]() ![]() ![]() |
SΣ | 1..1 | Identifier | Business Identifier for research subject in a study Required Pattern: At least the following |
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() |
0..1 | Period | Time period when id is/was valid for use | |
![]() ![]() ![]() ![]() |
0..1 | Reference(Organization) | Organization that issued id (may be just text) | |
![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() |
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) |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: ANON | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |
![]() ![]() ![]() ![]() |
SΣ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
![]() ![]() ![]() ![]() |
SΣ | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() |
?!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. |
![]() ![]() |
SΣ | 1..1 | Period | Start and end of participation. |
![]() ![]() ![]() |
SΣC | 1..1 | dateTime | Starting time with inclusive boundary |
![]() ![]() ![]() |
SΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
![]() ![]() |
SΣ | 1..1 | Reference(ResearchStudy) | study subject is part of |
![]() ![]() |
SΣ | 1..1 | Reference(Patient) | Who is part of study. |
![]() ![]() |
S | 1..1 | Reference(Consent) | Agreement to participate in study |
Documentation for this format | ||||
| 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. |
| 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()
|
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
![]() ![]() |
S | 0..1 | id | Logical id of this artifact |
![]() ![]() |
S | 0..1 | Meta | Metadata about the resource |
![]() ![]() ![]() |
S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
![]() ![]() |
S | 1..* | Identifier | Business Identifier for study subject. Slice: Unordered, Open by pattern:$this |
![]() ![]() ![]() |
S | 1..1 | Identifier | Business Identifier for research subject in a study Required Pattern: At least the following |
![]() ![]() ![]() ![]() |
S | 0..1 | CodeableConcept | Description of identifier Fixed Value: (Complex) |
![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: ANON | |
![]() ![]() ![]() ![]() |
S | 1..1 | uri | The namespace for the identifier value |
![]() ![]() ![]() ![]() |
S | 1..1 | string | The value that is unique |
![]() ![]() |
S | 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 |
![]() ![]() |
S | 1..1 | Period | Start and end of participation. |
![]() ![]() ![]() |
S | 1..1 | dateTime | Starting time with inclusive boundary |
![]() ![]() ![]() |
S | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
![]() ![]() |
S | 1..1 | Reference(ResearchStudy) | study subject is part of |
![]() ![]() |
S | 1..1 | Reference(Patient) | Who is part of study. |
![]() ![]() |
S | 1..1 | Reference(Consent) | Agreement to participate in study |
Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
![]() ![]() |
SΣ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
SΣ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() |
Σ | 0..1 | id | Version specific identifier | ||||
![]() ![]() ![]() |
Σ | 0..1 | instant | When the resource version last changed | ||||
![]() ![]() ![]() |
Σ | 0..1 | uri | Identifies where the resource comes from | ||||
![]() ![]() ![]() |
SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
![]() ![]() ![]() |
Σ | 0..* | Coding | Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
![]() ![]() ![]() |
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". | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() |
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 | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
![]() ![]() |
SΣ | 1..* | Identifier | Business Identifier for study subject. Slice: Unordered, Open by pattern:$this | ||||
![]() ![]() ![]() |
SΣ | 1..1 | Identifier | Business Identifier for research subject in a study Required Pattern: At least the following | ||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() ![]() |
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) | ||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: ANON | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |||||
![]() ![]() ![]() ![]() |
SΣ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
![]() ![]() ![]() ![]() |
SΣ | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
![]() ![]() |
?!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. | ||||
![]() ![]() |
SΣ | 1..1 | Period | Start and end of participation. | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() |
SΣC | 1..1 | dateTime | Starting time with inclusive boundary | ||||
![]() ![]() ![]() |
SΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | ||||
![]() ![]() |
SΣ | 1..1 | Reference(ResearchStudy) | study subject is part of | ||||
![]() ![]() |
SΣ | 1..1 | Reference(Patient) | Who is part of study. | ||||
![]() ![]() |
0..1 | string | What path should be followed | |||||
![]() ![]() |
0..1 | string | What path was followed | |||||
![]() ![]() |
S | 1..1 | Reference(Consent) | Agreement to participate in study | ||||
Documentation for this format | ||||||||
| 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. |
| 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:
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
![]() ![]() |
SΣ | 0..1 | id | Logical id of this artifact |
![]() ![]() |
SΣ | 0..1 | Meta | Metadata about the resource |
![]() ![]() ![]() |
SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored |
![]() ![]() |
SΣ | 1..* | Identifier | Business Identifier for study subject. Slice: Unordered, Open by pattern:$this |
![]() ![]() ![]() |
SΣ | 1..1 | Identifier | Business Identifier for research subject in a study Required Pattern: At least the following |
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() |
0..1 | Period | Time period when id is/was valid for use | |
![]() ![]() ![]() ![]() |
0..1 | Reference(Organization) | Organization that issued id (may be just text) | |
![]() ![]() ![]() ![]() |
?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
![]() ![]() ![]() ![]() |
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) |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: ANON | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |
![]() ![]() ![]() ![]() |
SΣ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
![]() ![]() ![]() ![]() |
SΣ | 1..1 | string | The value that is unique Example General: 123456 |
![]() ![]() |
?!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. |
![]() ![]() |
SΣ | 1..1 | Period | Start and end of participation. |
![]() ![]() ![]() |
SΣC | 1..1 | dateTime | Starting time with inclusive boundary |
![]() ![]() ![]() |
SΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
![]() ![]() |
SΣ | 1..1 | Reference(ResearchStudy) | study subject is part of |
![]() ![]() |
SΣ | 1..1 | Reference(Patient) | Who is part of study. |
![]() ![]() |
S | 1..1 | Reference(Consent) | Agreement to participate in study |
Documentation for this format | ||||
| 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. |
| 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
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
![]() ![]() |
S | 0..1 | id | Logical id of this artifact |
![]() ![]() |
S | 0..1 | Meta | Metadata about the resource |
![]() ![]() ![]() |
S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
![]() ![]() |
S | 1..* | Identifier | Business Identifier for study subject. Slice: Unordered, Open by pattern:$this |
![]() ![]() ![]() |
S | 1..1 | Identifier | Business Identifier for research subject in a study Required Pattern: At least the following |
![]() ![]() ![]() ![]() |
S | 0..1 | CodeableConcept | Description of identifier Fixed Value: (Complex) |
![]() ![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 | |
![]() ![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: ANON | |
![]() ![]() ![]() ![]() |
S | 1..1 | uri | The namespace for the identifier value |
![]() ![]() ![]() ![]() |
S | 1..1 | string | The value that is unique |
![]() ![]() |
S | 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 |
![]() ![]() |
S | 1..1 | Period | Start and end of participation. |
![]() ![]() ![]() |
S | 1..1 | dateTime | Starting time with inclusive boundary |
![]() ![]() ![]() |
S | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
![]() ![]() |
S | 1..1 | Reference(ResearchStudy) | study subject is part of |
![]() ![]() |
S | 1..1 | Reference(Patient) | Who is part of study. |
![]() ![]() |
S | 1..1 | Reference(Consent) | Agreement to participate in study |
Documentation for this format | ||||
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
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SΣ | 0..1 | id | Logical id of this artifact | ||||
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SΣ | 0..1 | Meta | Metadata about the resource | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | id | Version specific identifier | ||||
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Σ | 0..1 | instant | When the resource version last changed | ||||
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Σ | 0..1 | uri | Identifies where the resource comes from | ||||
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SΣ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
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Σ | 0..* | Coding | Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
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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". | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
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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 | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||
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SΣ | 1..* | Identifier | Business Identifier for study subject. Slice: Unordered, Open by pattern:$this | ||||
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SΣ | 1..1 | Identifier | Business Identifier for research subject in a study Required Pattern: At least the following | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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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) | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203 | |||||
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0..1 | string | Version of the system - if relevant | |||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: ANON | |||||
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0..1 | string | Representation defined by the system | |||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||
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0..1 | string | Plain text representation of the concept | |||||
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SΣ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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SΣ | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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?!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. | ||||
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SΣ | 1..1 | Period | Start and end of participation. | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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SΣC | 1..1 | dateTime | Starting time with inclusive boundary | ||||
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SΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | ||||
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SΣ | 1..1 | Reference(ResearchStudy) | study subject is part of | ||||
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SΣ | 1..1 | Reference(Patient) | Who is part of study. | ||||
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0..1 | string | What path should be followed | |||||
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0..1 | string | What path was followed | |||||
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S | 1..1 | Reference(Consent) | Agreement to participate in study | ||||
Documentation for this format | ||||||||
| 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. |
| 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()
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Summary
Mandatory: 7 elements
Must-Support: 15 elements
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron