Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.2.1 - ci-build
Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.2.1 - ci-build
Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy | Version: 0.2.1 | |||
| Draft as of 2024-01-11 | Computable Name: ECLAIREResearchStudy | |||
Profil de ResearchStudy pour le projet ECLAIRE
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
  eclaire-review-date | S | 0..1 | instant | Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date |
| eclaire-therapeutic-area | S | 0..1 | string | Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area |
| eclaire-recruitment-period | S | 0..1 | Period | Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period |
| eclaire-secondary-sponsor | S | 0..* | Reference(Organization) | Promoteur(s) secondaire(s) / Secondary Sponsor(s) URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor |
| eclaire-label-r5 | S | 0..* | (Complex) | autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label |
  Slices for identifier | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use | |
  identifier:idPrimary | S | 0..1 | Identifier | Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number |
   use | 1..1 | code | usual | official | temp | secondary | old (If known) Required Pattern: official | |
 identifier:idSecondary | S | 0..* | Identifier | identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. |
 use | 1..1 | code | usual | official | temp | secondary | old (If known) Required Pattern: secondary | |
| title | S | 0..1 | string | Nom scientifique de l'étude / Scientific Title |
| status | S | 1..1 | code | Statut de l'essai / Study Status |
| phase | S | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) |
| category | S | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) |
| Slices for condition | S | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by |
| condition:medDRACondition | S | 0..* | CodeableConcept | code MedDRA / MedDRA condition |
 id | 0..1 | string | Unique id for inter-element referencing Required Pattern: meddra-condition | |
 coding | ||||
 system | 0..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/mdr | |
| condition:diseaseCondition | S | 0..* | CodeableConcept | condition de la pathologie / Disease Condition |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: disease-condition | |
| text | 1..1 | string | Plain text representation of the concept | |
| contact | S | 0..* | ContactDetail | Contact (Contact for public / scientific queries) |
| eclaire-contact-type | S | 0..1 | CodeableConcept | Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) |
| eclaire-contact-address | S | 0..1 | Address | Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address |
| eclaire-contact-affiliation | S | 0..1 | string | Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation |
| eclaire-contact-name | 0..1 | HumanName | Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name | |
| location | S | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment |
| description | S | 0..1 | markdown | Résumé de l'essai / Summary Results |
| enrollment | S | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria |
| sponsor | S | 0..1 | Reference(Organization) | Promoteur / primary Sponsor |
| site | S | 0..* | Reference(Location) | Lieux / Countries of Recruitment |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| ResearchStudy.phase | extensible | EclaireStudyPhaseVS |
| ResearchStudy.category | extensible | EclaireCategoryVS |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| eclaire-review-date | S | 0..1 | instant | Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date |
| eclaire-therapeutic-area | S | 0..1 | string | Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area |
| eclaire-recruitment-period | S | 0..1 | Period | Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period |
| eclaire-secondary-sponsor | S | 0..* | Reference(Organization) | Promoteur(s) secondaire(s) / Secondary Sponsor(s) URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor |
| eclaire-label-r5 | S | 0..* | (Complex) | autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label |
 modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url |
| Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use |
| identifier:idPrimary | SΣ | 0..1 | Identifier | Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number |
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: official |
| identifier:idSecondary | SΣ | 0..* | Identifier | identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. |
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: secondary |
| title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title |
| status | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
 phase | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) |
| category | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) |
| Slices for condition | SΣ | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| condition:medDRACondition | SΣ | 0..* | CodeableConcept | code MedDRA / MedDRA condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: meddra-condition | |
| condition:diseaseCondition | SΣ | 0..* | CodeableConcept | condition de la pathologie / Disease Condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: disease-condition | |
| text | Σ | 1..1 | string | Plain text representation of the concept |
| contact | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) |
| eclaire-contact-type | S | 0..1 | CodeableConcept | Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) |
| eclaire-contact-address | S | 0..1 | Address | Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address |
| eclaire-contact-affiliation | S | 0..1 | string | Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation |
| eclaire-contact-name | 0..1 | HumanName | Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name | |
| location | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. |
| description | S | 0..1 | markdown | Résumé de l'essai / Summary Results |
 enrollment | SΣC | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria |
| sponsor | SΣC | 0..1 | Reference(Organization) | Promoteur / primary Sponsor |
| site | SΣC | 0..* | Reference(Location) | Lieux / Countries of Recruitment |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ResearchStudy.identifier:idPrimary.use | required | Pattern: official |
| ResearchStudy.identifier:idSecondary.use | required | Pattern: secondary |
| ResearchStudy.status | required | ResearchStudyStatus |
| ResearchStudy.phase | extensible | EclaireStudyPhaseVS |
| ResearchStudy.category | extensible | EclaireCategoryVS |
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.condition:medDRACondition | example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.condition:diseaseCondition | example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.location | extensible | Jurisdiction ValueSet |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | 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 | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | 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 | ResearchStudy.extension:eclaire-review-date, ResearchStudy.extension:eclaire-therapeutic-area, ResearchStudy.extension:eclaire-recruitment-period, ResearchStudy.extension:eclaire-secondary-sponsor, ResearchStudy.extension:eclaire-label-r5, ResearchStudy.modifierExtension, ResearchStudy.contact.extension:eclaire-contact-type, ResearchStudy.contact.extension:eclaire-contact-address, ResearchStudy.contact.extension:eclaire-contact-affiliation, ResearchStudy.contact.extension:eclaire-contact-name | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ref-1 | error | ResearchStudy.enrollment, ResearchStudy.sponsor, ResearchStudy.site | SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | |||||
 Slices for extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| eclaire-review-date | S | 0..1 | instant | Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date | ||||
| eclaire-therapeutic-area | S | 0..1 | string | Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area | ||||
| eclaire-recruitment-period | S | 0..1 | Period | Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period | ||||
| eclaire-secondary-sponsor | S | 0..* | Reference(Organization) | Promoteur(s) secondaire(s) / Secondary Sponsor(s) URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor | ||||
| eclaire-label-r5 | S | 0..* | (Complex) | autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label | ||||
| modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | ||||
| Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use | ||||
| identifier:idPrimary | SΣ | 0..1 | Identifier | Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: official | ||||
| type | Σ | 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 | Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period | ΣC | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | ΣC | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| identifier:idSecondary | SΣ | 0..* | Identifier | identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: secondary | ||||
| type | Σ | 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 | Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period | ΣC | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | ΣC | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title | ||||
| protocol | ΣC | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf | ΣC | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| status | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status 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 | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) | ||||
| category | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) | ||||
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions. | ||||
| Slices for condition | SΣ | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| condition:medDRACondition | SΣ | 0..* | CodeableConcept | code MedDRA / MedDRA condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: meddra-condition | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
 coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
 id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/mdr | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 0..1 | string | Representation defined by the system | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| condition:diseaseCondition | SΣ | 0..* | CodeableConcept | condition de la pathologie / Disease Condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: disease-condition | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 1..1 | string | Plain text representation of the concept | ||||
| contact | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| eclaire-contact-type | S | 0..1 | CodeableConcept | Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) | ||||
| eclaire-contact-address | S | 0..1 | Address | Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address | ||||
| eclaire-contact-affiliation | S | 0..1 | string | Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation | ||||
| eclaire-contact-name | 0..1 | HumanName | Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name | |||||
| name | Σ | 0..1 | string | Name of an individual to contact | ||||
| telecom | ΣC | 0..* | ContactPoint | Contact details for individual or organization | ||||
| relatedArtifact | 0..* | RelatedArtifact | References and dependencies | |||||
| keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery. | ||||
| location | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| description | S | 0..1 | markdown | Résumé de l'essai / Summary Results | ||||
| enrollment | SΣC | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria | ||||
| period | ΣC | 0..1 | Period | When the study began and ended | ||||
| sponsor | SΣC | 0..1 | Reference(Organization) | Promoteur / primary Sponsor | ||||
| principalInvestigator | ΣC | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
| site | SΣC | 0..* | Reference(Location) | Lieux / Countries of Recruitment | ||||
| 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 | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| 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 | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| 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 | Conformance | ValueSet / Code | ||||
| ResearchStudy.language | preferred | CommonLanguages
| ||||
| ResearchStudy.identifier:idPrimary.use | required | Pattern: official | ||||
| ResearchStudy.identifier:idPrimary.type | extensible | Identifier Type Codes | ||||
| ResearchStudy.identifier:idSecondary.use | required | Pattern: secondary | ||||
| ResearchStudy.identifier:idSecondary.type | extensible | Identifier Type Codes | ||||
| ResearchStudy.status | required | ResearchStudyStatus | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType | ||||
| ResearchStudy.phase | extensible | EclaireStudyPhaseVS | ||||
| ResearchStudy.category | extensible | EclaireCategoryVS | ||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.condition:medDRACondition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.condition:diseaseCondition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSet | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType |
| Id | Grade | Path(s) | Details | Requirements |
| cpt-2 | error | ResearchStudy.contact.telecom | A system is required if a value is provided. : value.empty() or system.exists() | |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | 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 | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | 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 | ResearchStudy.extension, ResearchStudy.extension:eclaire-review-date, ResearchStudy.extension:eclaire-therapeutic-area, ResearchStudy.extension:eclaire-recruitment-period, ResearchStudy.extension:eclaire-secondary-sponsor, ResearchStudy.extension:eclaire-label-r5, ResearchStudy.modifierExtension, ResearchStudy.identifier:idPrimary.extension, ResearchStudy.identifier:idSecondary.extension, ResearchStudy.condition:medDRACondition.extension, ResearchStudy.condition:medDRACondition.coding.extension, ResearchStudy.condition:diseaseCondition.extension, ResearchStudy.contact.extension, ResearchStudy.contact.extension:eclaire-contact-type, ResearchStudy.contact.extension:eclaire-contact-address, ResearchStudy.contact.extension:eclaire-contact-affiliation, ResearchStudy.contact.extension:eclaire-contact-name, ResearchStudy.arm.extension, ResearchStudy.arm.modifierExtension, ResearchStudy.objective.extension, ResearchStudy.objective.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| per-1 | error | ResearchStudy.identifier:idPrimary.period, ResearchStudy.identifier:idSecondary.period, ResearchStudy.period | If present, start SHALL have a lower value than end : start.hasValue().not() or end.hasValue().not() or (start <= end) | |
| ref-1 | error | ResearchStudy.identifier:idPrimary.assigner, ResearchStudy.identifier:idSecondary.assigner, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.enrollment, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site | SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) |
This structure is derived from ResearchStudy
Summary
Mandatory: 0 element (3 nested mandatory elements)
Must-Support: 23 elements
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| eclaire-review-date | S | 0..1 | instant | Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date |
| eclaire-therapeutic-area | S | 0..1 | string | Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area |
| eclaire-recruitment-period | S | 0..1 | Period | Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period |
| eclaire-secondary-sponsor | S | 0..* | Reference(Organization) | Promoteur(s) secondaire(s) / Secondary Sponsor(s) URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor |
| eclaire-label-r5 | S | 0..* | (Complex) | autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label |
| Slices for identifier | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use | |
| identifier:idPrimary | S | 0..1 | Identifier | Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number |
| use | 1..1 | code | usual | official | temp | secondary | old (If known) Required Pattern: official | |
| identifier:idSecondary | S | 0..* | Identifier | identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. |
| use | 1..1 | code | usual | official | temp | secondary | old (If known) Required Pattern: secondary | |
| title | S | 0..1 | string | Nom scientifique de l'étude / Scientific Title |
| status | S | 1..1 | code | Statut de l'essai / Study Status |
| phase | S | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) |
| category | S | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) |
| Slices for condition | S | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by |
| condition:medDRACondition | S | 0..* | CodeableConcept | code MedDRA / MedDRA condition |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: meddra-condition | |
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/mdr | |
| condition:diseaseCondition | S | 0..* | CodeableConcept | condition de la pathologie / Disease Condition |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: disease-condition | |
| text | 1..1 | string | Plain text representation of the concept | |
| contact | S | 0..* | ContactDetail | Contact (Contact for public / scientific queries) |
| eclaire-contact-type | S | 0..1 | CodeableConcept | Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) |
| eclaire-contact-address | S | 0..1 | Address | Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address |
| eclaire-contact-affiliation | S | 0..1 | string | Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation |
| eclaire-contact-name | 0..1 | HumanName | Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name | |
| location | S | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment |
| description | S | 0..1 | markdown | Résumé de l'essai / Summary Results |
| enrollment | S | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria |
| sponsor | S | 0..1 | Reference(Organization) | Promoteur / primary Sponsor |
| site | S | 0..* | Reference(Location) | Lieux / Countries of Recruitment |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| ResearchStudy.phase | extensible | EclaireStudyPhaseVS |
| ResearchStudy.category | extensible | EclaireCategoryVS |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| eclaire-review-date | S | 0..1 | instant | Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date |
| eclaire-therapeutic-area | S | 0..1 | string | Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area |
| eclaire-recruitment-period | S | 0..1 | Period | Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period |
| eclaire-secondary-sponsor | S | 0..* | Reference(Organization) | Promoteur(s) secondaire(s) / Secondary Sponsor(s) URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor |
| eclaire-label-r5 | S | 0..* | (Complex) | autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label |
| modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url |
| Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use |
| identifier:idPrimary | SΣ | 0..1 | Identifier | Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number |
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: official |
| identifier:idSecondary | SΣ | 0..* | Identifier | identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. |
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: secondary |
| title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title |
| status | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
| phase | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) |
| category | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) |
| Slices for condition | SΣ | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| condition:medDRACondition | SΣ | 0..* | CodeableConcept | code MedDRA / MedDRA condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: meddra-condition | |
| condition:diseaseCondition | SΣ | 0..* | CodeableConcept | condition de la pathologie / Disease Condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. |
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: disease-condition | |
| text | Σ | 1..1 | string | Plain text representation of the concept |
| contact | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) |
| eclaire-contact-type | S | 0..1 | CodeableConcept | Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) |
| eclaire-contact-address | S | 0..1 | Address | Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address |
| eclaire-contact-affiliation | S | 0..1 | string | Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation |
| eclaire-contact-name | 0..1 | HumanName | Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name | |
| location | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. |
| description | S | 0..1 | markdown | Résumé de l'essai / Summary Results |
| enrollment | SΣC | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria |
| sponsor | SΣC | 0..1 | Reference(Organization) | Promoteur / primary Sponsor |
| site | SΣC | 0..* | Reference(Location) | Lieux / Countries of Recruitment |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| ResearchStudy.identifier:idPrimary.use | required | Pattern: official |
| ResearchStudy.identifier:idSecondary.use | required | Pattern: secondary |
| ResearchStudy.status | required | ResearchStudyStatus |
| ResearchStudy.phase | extensible | EclaireStudyPhaseVS |
| ResearchStudy.category | extensible | EclaireCategoryVS |
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.condition:medDRACondition | example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.condition:diseaseCondition | example | Condition/Problem/DiagnosisCodes |
| ResearchStudy.location | extensible | Jurisdiction ValueSet |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | 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 | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | 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 | ResearchStudy.extension:eclaire-review-date, ResearchStudy.extension:eclaire-therapeutic-area, ResearchStudy.extension:eclaire-recruitment-period, ResearchStudy.extension:eclaire-secondary-sponsor, ResearchStudy.extension:eclaire-label-r5, ResearchStudy.modifierExtension, ResearchStudy.contact.extension:eclaire-contact-type, ResearchStudy.contact.extension:eclaire-contact-address, ResearchStudy.contact.extension:eclaire-contact-affiliation, ResearchStudy.contact.extension:eclaire-contact-name | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ref-1 | error | ResearchStudy.enrollment, ResearchStudy.sponsor, ResearchStudy.site | SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | |||||
| Slices for extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| eclaire-review-date | S | 0..1 | instant | Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date | ||||
| eclaire-therapeutic-area | S | 0..1 | string | Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area | ||||
| eclaire-recruitment-period | S | 0..1 | Period | Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period | ||||
| eclaire-secondary-sponsor | S | 0..* | Reference(Organization) | Promoteur(s) secondaire(s) / Secondary Sponsor(s) URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-secondary-sponsor | ||||
| eclaire-label-r5 | S | 0..* | (Complex) | autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label | ||||
| modifierExtension | ?!N | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | ||||
| Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use | ||||
| identifier:idPrimary | SΣ | 0..1 | Identifier | Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: official | ||||
| type | Σ | 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 | Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period | ΣC | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | ΣC | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| identifier:idSecondary | SΣ | 0..* | Identifier | identifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| use | ?!Σ | 1..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . Required Pattern: secondary | ||||
| type | Σ | 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 | Σ | 0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
| value | Σ | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period | ΣC | 0..1 | Period | Time period when id is/was valid for use | ||||
| assigner | ΣC | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
| title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title | ||||
| protocol | ΣC | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf | ΣC | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| status | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status 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 | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) | ||||
| category | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) | ||||
| focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions. | ||||
| Slices for condition | SΣ | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| condition:medDRACondition | SΣ | 0..* | CodeableConcept | code MedDRA / MedDRA condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: meddra-condition | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| system | Σ | 0..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/mdr | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 0..1 | string | Representation defined by the system | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | Σ | 0..1 | string | Plain text representation of the concept | ||||
| condition:diseaseCondition | SΣ | 0..* | CodeableConcept | condition de la pathologie / Disease Condition Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| id | 0..1 | string | Unique id for inter-element referencing Required Pattern: disease-condition | |||||
| extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | Σ | 1..1 | string | Plain text representation of the concept | ||||
| contact | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| eclaire-contact-type | S | 0..1 | CodeableConcept | Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) | ||||
| eclaire-contact-address | S | 0..1 | Address | Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address | ||||
| eclaire-contact-affiliation | S | 0..1 | string | Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation | ||||
| eclaire-contact-name | 0..1 | HumanName | Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name | |||||
| name | Σ | 0..1 | string | Name of an individual to contact | ||||
| telecom | ΣC | 0..* | ContactPoint | Contact details for individual or organization | ||||
| relatedArtifact | 0..* | RelatedArtifact | References and dependencies | |||||
| keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery. | ||||
| location | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| description | S | 0..1 | markdown | Résumé de l'essai / Summary Results | ||||
| enrollment | SΣC | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria | ||||
| period | ΣC | 0..1 | Period | When the study began and ended | ||||
| sponsor | SΣC | 0..1 | Reference(Organization) | Promoteur / primary Sponsor | ||||
| principalInvestigator | ΣC | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
| site | SΣC | 0..* | Reference(Location) | Lieux / Countries of Recruitment | ||||
| 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 | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| 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 | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||
| 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 | Conformance | ValueSet / Code | ||||
| ResearchStudy.language | preferred | CommonLanguages
| ||||
| ResearchStudy.identifier:idPrimary.use | required | Pattern: official | ||||
| ResearchStudy.identifier:idPrimary.type | extensible | Identifier Type Codes | ||||
| ResearchStudy.identifier:idSecondary.use | required | Pattern: secondary | ||||
| ResearchStudy.identifier:idSecondary.type | extensible | Identifier Type Codes | ||||
| ResearchStudy.status | required | ResearchStudyStatus | ||||
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType | ||||
| ResearchStudy.phase | extensible | EclaireStudyPhaseVS | ||||
| ResearchStudy.category | extensible | EclaireCategoryVS | ||||
| ResearchStudy.focus | example | |||||
| ResearchStudy.condition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.condition:medDRACondition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.condition:diseaseCondition | example | Condition/Problem/DiagnosisCodes | ||||
| ResearchStudy.keyword | example | |||||
| ResearchStudy.location | extensible | Jurisdiction ValueSet | ||||
| ResearchStudy.reasonStopped | example | ResearchStudyReasonStopped | ||||
| ResearchStudy.objective.type | preferred | ResearchStudyObjectiveType |
| Id | Grade | Path(s) | Details | Requirements |
| cpt-2 | error | ResearchStudy.contact.telecom | A system is required if a value is provided. : value.empty() or system.exists() | |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ResearchStudy | 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 | ResearchStudy | 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 | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ResearchStudy | 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 | ResearchStudy.extension, ResearchStudy.extension:eclaire-review-date, ResearchStudy.extension:eclaire-therapeutic-area, ResearchStudy.extension:eclaire-recruitment-period, ResearchStudy.extension:eclaire-secondary-sponsor, ResearchStudy.extension:eclaire-label-r5, ResearchStudy.modifierExtension, ResearchStudy.identifier:idPrimary.extension, ResearchStudy.identifier:idSecondary.extension, ResearchStudy.condition:medDRACondition.extension, ResearchStudy.condition:medDRACondition.coding.extension, ResearchStudy.condition:diseaseCondition.extension, ResearchStudy.contact.extension, ResearchStudy.contact.extension:eclaire-contact-type, ResearchStudy.contact.extension:eclaire-contact-address, ResearchStudy.contact.extension:eclaire-contact-affiliation, ResearchStudy.contact.extension:eclaire-contact-name, ResearchStudy.arm.extension, ResearchStudy.arm.modifierExtension, ResearchStudy.objective.extension, ResearchStudy.objective.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| per-1 | error | ResearchStudy.identifier:idPrimary.period, ResearchStudy.identifier:idSecondary.period, ResearchStudy.period | If present, start SHALL have a lower value than end : start.hasValue().not() or end.hasValue().not() or (start <= end) | |
| ref-1 | error | ResearchStudy.identifier:idPrimary.assigner, ResearchStudy.identifier:idSecondary.assigner, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.enrollment, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site | SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) |
This structure is derived from ResearchStudy
Summary
Mandatory: 0 element (3 nested mandatory elements)
Must-Support: 23 elements
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron