FHIR Osiris Implementation Guide
1.1.0 - trial-implementation
FHIR Osiris Implementation Guide
1.1.0 - trial-implementation
This page is part of the OSIRIS FHIR Implementation Guide (v1.1.0: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
| Official URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/clinical-trial-subject | Version: 1.1.0 | |||
| Draft as of 2025-04-03 | Computable Name: ClinicalTrialSubject | |||
Subject that belongs to a oncology-related Clinical Trial.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
  ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| status |
?!Σ | 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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. ele-1: All FHIR elements must have a @value or children |
 study |
Σ | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of ele-1: All FHIR elements must have a @value or children |
 individual |
Σ | 1..1 | Reference(Oncology Patient) | Who is part of study ele-1: All FHIR elements must have a @value or children |
| Documentation for this format | ||||
| Path | Conformité | ValueSet | URI |
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
This structure is derived from ResearchSubject
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| study |
1..1 | Reference(Oncology Clinical Trial) | Study subject is part of | |
| individual |
1..1 | Reference(Oncology Patient) | Who is part of study | |
| Documentation for this format | ||||
| Nom | Drapeaux | Card. | Type | Description et contraintes | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
 meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| 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 | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!Σ | 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 |
Σ | 0..1 | Period | Start and end of participation | ||||
| study |
Σ | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of | ||||
| individual |
Σ | 1..1 | Reference(Oncology Patient) | Who is part of study | ||||
| assignedArm |
0..1 | string | What path should be followed | |||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
0..1 | Reference(Consent) | Agreement to participate in study | |||||
| Documentation for this format | ||||||||
| Path | Conformité | ValueSet | URI | |||
| ResearchSubject.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard
| ||||
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
This structure is derived from ResearchSubject
Key Elements View
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| status |
?!Σ | 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. ele-1: All FHIR elements must have a @value or children |
| study |
Σ | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of ele-1: All FHIR elements must have a @value or children |
| individual |
Σ | 1..1 | Reference(Oncology Patient) | Who is part of study ele-1: All FHIR elements must have a @value or children |
| Documentation for this format | ||||
| Path | Conformité | ValueSet | URI |
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
Differential View
This structure is derived from ResearchSubject
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| study |
1..1 | Reference(Oncology Clinical Trial) | Study subject is part of | |
| individual |
1..1 | Reference(Oncology Patient) | Who is part of study | |
| Documentation for this format | ||||
Snapshot View
| Nom | Drapeaux | Card. | Type | Description et contraintes | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| 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 | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for research subject in a study | ||||
| status |
?!Σ | 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 |
Σ | 0..1 | Period | Start and end of participation | ||||
| study |
Σ | 1..1 | Reference(Oncology Clinical Trial) | Study subject is part of | ||||
| individual |
Σ | 1..1 | Reference(Oncology Patient) | Who is part of study | ||||
| assignedArm |
0..1 | string | What path should be followed | |||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
0..1 | Reference(Consent) | Agreement to participate in study | |||||
| Documentation for this format | ||||||||
| Path | Conformité | ValueSet | URI | |||
| ResearchSubject.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard
| ||||
| ResearchSubject.status | required | ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1from the FHIR Standard |
This structure is derived from ResearchSubject
Other representations of profile: CSV, Excel, Schematron