FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

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## Resource Profile: Clinical Trial Subject

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:

- This Resource Profile is not used by any profiles in this Implementation Guide

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.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

#### Terminology Bindings

Path | Conformité | ValueSet | URI
ResearchSubject.status | required | ResearchSubjectStatus `http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1` from 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.
Bindings Additionnels | But
AllLanguages | Binding Max
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

#### Terminology Bindings

Path | Conformité | ValueSet | URI
ResearchSubject.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Bindings Additionnels | But
AllLanguages | Binding Max
ResearchSubject.status | required | ResearchSubjectStatus `http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1` from the FHIR Standard

This structure is derived from ResearchSubject

Résumé

Structures

This structure refers to these other structures:

- Oncology Clinical Trial (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/clinical-trial)
- Oncology Patient (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-patient)

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

#### Terminology Bindings

Path | Conformité | ValueSet | URI
ResearchSubject.status | required | ResearchSubjectStatus `http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1` from 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.
Bindings Additionnels | But
AllLanguages | Binding Max
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

#### Terminology Bindings

Path | Conformité | ValueSet | URI
ResearchSubject.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Bindings Additionnels | But
AllLanguages | Binding Max
ResearchSubject.status | required | ResearchSubjectStatus `http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1` from the FHIR Standard

This structure is derived from ResearchSubject

Résumé

Structures

This structure refers to these other structures:

- Oncology Clinical Trial (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/clinical-trial)
- Oncology Patient (https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-patient)

Other representations of profile: CSV, Excel, Schematron