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 | Version: 1.1.0 | |||
| Draft as of 2025-04-03 | Computable Name: ClinicalTrial | |||
Oncology clinical trial used to associate a Onco Patient to a Clinical Trial
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
  ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge 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 |
 identifier |
Σ | 1..1 | Identifier | EudraCT number of the clinical trial ele-1: All FHIR elements must have a @value or children |
| title |
SΣ | 1..1 | string | Clinical trial name ele-1: All FHIR elements must have a @value or children |
 status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. ele-1: All FHIR elements must have a @value or children |
| Documentation for this format | ||||
| Path | Conformité | ValueSet | URI |
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1from the FHIR Standard |
This structure is derived from ResearchStudy
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
 identifier |
1..1 | Identifier | EudraCT number of the clinical trial | |
| title |
S | 1..1 | string | Clinical trial name |
| Documentation for this format | ||||
| Nom | Drapeaux | Card. | Type | Description et contraintes | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
| 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 | 1..1 | Identifier | EudraCT number of the clinical trial | ||||
| title |
SΣ | 1..1 | string | Clinical trial name | ||||
 protocol |
Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
| primaryPurposeType |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study. | ||||
| phase |
Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | ||||
| category |
Σ | 0..* | CodeableConcept | Classifications for the study Binding Description (No ValueSet): (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| focus |
Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions. | ||||
| condition |
Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| contact |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
| relatedArtifact |
0..* | RelatedArtifact | References and dependencies | |||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery. | ||||
| location |
Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| description |
0..1 | markdown | What this is study doing | |||||
| enrollment |
Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
| site |
Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
| reasonStopped |
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
| note |
0..* | Annotation | Comments made about the study | |||||
 arm |
0..* | BackboneElement | Defined path through the study for a subject | |||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
1..1 | string | Label for study arm | |||||
| type |
0..1 | CodeableConcept | Categorization of study arm | |||||
| description |
0..1 | string | Short explanation of study path | |||||
 objective |
0..* | BackboneElement | A goal for the study | |||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
0..1 | string | Label for the objective | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
| Documentation for this format | ||||||||
| Path | Conformité | ValueSet | URI | |||
| ResearchStudy.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard
| ||||
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1from the FHIR Standard | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-typefrom the FHIR Standard | ||||
| ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phasefrom the FHIR Standard | ||||
| ResearchStudy.category | example | |||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stoppedfrom the FHIR Standard | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard |
This structure is derived from ResearchStudy
Key Elements View
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge 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 |
| identifier |
Σ | 1..1 | Identifier | EudraCT number of the clinical trial ele-1: All FHIR elements must have a @value or children |
| title |
SΣ | 1..1 | string | Clinical trial name ele-1: All FHIR elements must have a @value or children |
| status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. ele-1: All FHIR elements must have a @value or children |
| Documentation for this format | ||||
| Path | Conformité | ValueSet | URI |
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1from the FHIR Standard |
Differential View
This structure is derived from ResearchStudy
| Nom | Drapeaux | Card. | Type | Description et contraintes |
|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| identifier |
1..1 | Identifier | EudraCT number of the clinical trial | |
| title |
S | 1..1 | string | Clinical trial name |
| Documentation for this format | ||||
Snapshot View
| Nom | Drapeaux | Card. | Type | Description et contraintes | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
| 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 | 1..1 | Identifier | EudraCT number of the clinical trial | ||||
| title |
SΣ | 1..1 | string | Clinical trial name | ||||
| protocol |
Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
| primaryPurposeType |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study. | ||||
| phase |
Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | ||||
| category |
Σ | 0..* | CodeableConcept | Classifications for the study Binding Description (No ValueSet): (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| focus |
Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions. | ||||
| condition |
Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| contact |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
| relatedArtifact |
0..* | RelatedArtifact | References and dependencies | |||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery. | ||||
| location |
Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| description |
0..1 | markdown | What this is study doing | |||||
| enrollment |
Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
| site |
Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
| reasonStopped |
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
| note |
0..* | Annotation | Comments made about the study | |||||
| arm |
0..* | BackboneElement | Defined path through the study for a subject | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
1..1 | string | Label for study arm | |||||
| type |
0..1 | CodeableConcept | Categorization of study arm | |||||
| description |
0..1 | string | Short explanation of study path | |||||
| objective |
0..* | BackboneElement | A goal for the study | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
0..1 | string | Label for the objective | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
| Documentation for this format | ||||||||
| Path | Conformité | ValueSet | URI | |||
| ResearchStudy.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard
| ||||
| ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1from the FHIR Standard | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-typefrom the FHIR Standard | ||||
| ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phasefrom the FHIR Standard | ||||
| ResearchStudy.category | example | |||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-codefrom the FHIR Standard | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stoppedfrom the FHIR Standard | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-typefrom the FHIR Standard |
This structure is derived from ResearchStudy
Other representations of profile: CSV, Excel, Schematron