German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: https://www.vision-zero-oncology.de/fhir/StructureDefinition/probandin | Version: 0.1.0 | |||
| Active as of 2023-12-13 | Computable Name: Probandin | |||
Copyright/Legal: CC-BY-SA-4.0 |
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Dieses Profil beschreibt eine Proband*in.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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 |
 source | S | 0..1 | uri | Identifies where the resource comes from |
 profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
 Slices for identifier | S | 1..* | Identifier | Business Identifier for research subject in a study 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 | 1..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 | |
 type | S | 0..1 | CodeableConcept | Description of identifier |
| system | S | 1..1 | uri | The namespace for the identifier value |
 value | S | 1..1 | string | The value that is unique |
| status | 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn |
| 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 |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| source | SΣ | 0..1 | uri | Identifies where the resource comes from |
| 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 |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| Slices for identifier | SΣ | 1..* | Identifier | Business Identifier for research subject in a study 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 |
| type | 1..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 | |
| 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. |
| 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 |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| ResearchSubject.identifier:subjectIdentificationCode.use | required | IdentifierUse |
| ResearchSubject.identifier:subjectIdentificationCode.type | extensible | Identifier Type Codes |
| ResearchSubject.status | required | ResearchSubjectStatus |
| Id | Grade | Path(s) | Details | Requirements |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | SΣ | 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 | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| 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 research subject in a study 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 | |||||
| use | 0..1 | code | usual | official | temp | secondary | old (If known) | |||||
| type | 1..1 | CodeableConcept | Description of identifier 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 | 0..1 | uri | The namespace for the identifier value | |||||
| value | 0..1 | string | The value that is unique | |||||
| 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) | |||||
| 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. | ||||
| 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 | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| ResearchSubject.meta.security | extensible | All Security Labels | ||||
| ResearchSubject.meta.tag | example | CommonTags | ||||
| ResearchSubject.language | preferred | CommonLanguages
| ||||
| ResearchSubject.identifier:subjectIdentificationCode.use | required | IdentifierUse | ||||
| ResearchSubject.identifier:subjectIdentificationCode.type | extensible | Identifier Type Codes | ||||
| ResearchSubject.status | required | ResearchSubjectStatus |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
This structure is derived from ResearchSubject
Summary
Mandatory: 7 elements
Must-Support: 16 elements
Slices
This structure defines the following Slices:
Differential View
This structure is derived from ResearchSubject
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| source | S | 0..1 | uri | Identifies where the resource comes from |
| profile | S | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| Slices for identifier | S | 1..* | Identifier | Business Identifier for research subject in a study 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 | 1..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 | |
| type | S | 0..1 | CodeableConcept | Description of identifier |
| system | S | 1..1 | uri | The namespace for the identifier value |
| value | S | 1..1 | string | The value that is unique |
| status | 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 |
| 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 |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| source | SΣ | 0..1 | uri | Identifies where the resource comes from |
| 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 |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| Slices for identifier | SΣ | 1..* | Identifier | Business Identifier for research subject in a study 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 |
| type | 1..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 | |
| 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. |
| 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 |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| ResearchSubject.identifier:subjectIdentificationCode.use | required | IdentifierUse |
| ResearchSubject.identifier:subjectIdentificationCode.type | extensible | Identifier Type Codes |
| ResearchSubject.status | required | ResearchSubjectStatus |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | SΣ | 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 | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| 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 research subject in a study 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 | |||||
| use | 0..1 | code | usual | official | temp | secondary | old (If known) | |||||
| type | 1..1 | CodeableConcept | Description of identifier 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 | 0..1 | uri | The namespace for the identifier value | |||||
| value | 0..1 | string | The value that is unique | |||||
| 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) | |||||
| 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. | ||||
| 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 | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| ResearchSubject.meta.security | extensible | All Security Labels | ||||
| ResearchSubject.meta.tag | example | CommonTags | ||||
| ResearchSubject.language | preferred | CommonLanguages
| ||||
| ResearchSubject.identifier:subjectIdentificationCode.use | required | IdentifierUse | ||||
| ResearchSubject.identifier:subjectIdentificationCode.type | extensible | Identifier Type Codes | ||||
| ResearchSubject.status | required | ResearchSubjectStatus |
| Id | Grade | Path(s) | Details | Requirements |
| 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() |
This structure is derived from ResearchSubject
Summary
Mandatory: 7 elements
Must-Support: 16 elements
Slices
This structure defines the following Slices:
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