Left: | ECLAIREResearchStudy (https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy) |
Right: | ECLAIREResearchStudy (https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy) |
Error | StructureDefinition.version | Values for version differ: '0.2.0' vs '0.3.0' |
Information | StructureDefinition.date | Values for date differ: '2023-10-24T08:16:05+00:00' vs '2024-02-26T09:56:13+00:00' |
Information | StructureDefinition.short | Values for short differ: 'Extension' vs 'Additional content defined by implementations' |
Information | StructureDefinition.definition | Values for definition differ: 'An Extension' vs 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
Information | StructureDefinition.short | Values for short differ: 'treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility' vs 'Objectif principal / Primary purpose' |
Warning | ResearchStudy.primaryPurposeType | Elements differ in definition for mustSupport: 'false' vs 'true' |
Information | StructureDefinition.short | Values for short differ: 'References and dependencies' vs 'Publications et résumé des résultats / Publications about the study and Summary results' |
Warning | ResearchStudy.relatedArtifact | Elements differ in definition for mustSupport: 'false' vs 'true' |
Information | StructureDefinition.short | Values for short differ: 'Résumé de l'essai / Summary Results' vs 'Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results' |
Information | StructureDefinition.short | Values for short differ: 'Promoteur / primary Sponsor' vs 'Organization that initiates and is legally responsible for the study' |
Warning | ResearchStudy.sponsor | Elements differ in definition for mustSupport: 'true' vs 'false' |
Information | ResearchStudy.sponsor | Element maximum cardinalities differ: '1' vs '0' |
Information | ResearchStudy.principalInvestigator | Element maximum cardinalities differ: '1' vs '0' |
Name | Value | Comments | |
---|---|---|---|
abstract | false | ||
baseDefinition | http://hl7.org/fhir/StructureDefinition/ResearchStudy | ||
copyright | |||
date | 2023-10-24T08:16:05+00:00 | 2024-02-26T09:56:13+00:00 |
|
description | Profil de ResearchStudy pour le projet ECLAIRE | ||
experimental | |||
fhirVersion | 4.0.1 | ||
jurisdiction | |||
jurisdiction[0] | urn:iso:std:iso:3166#FR | ||
kind | resource | ||
name | ECLAIREResearchStudy | ||
publisher | ANS | ||
purpose | |||
status | draft | ||
title | |||
type | ResearchStudy | ||
url | https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy | ||
version | 0.2.0 | 0.3.0 |
|
Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||||||||
id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||||||||
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?!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 | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:use | |||||||||
title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title | |||||||||
protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ΣC | 0..* | Reference(PlanDefinition) | Steps followed in executing study | |||||||||
partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ΣC | 0..* | Reference(ResearchStudy) | Part of larger study | |||||||||
status | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status Binding: ?? (required): Codes that convey the current status of the research study. | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status Binding: ?? (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: ?? (extensible): Codes for the main intent of the study. | SΣ | 0..1 | CodeableConcept | Objectif principal / Primary purpose Binding: ?? (extensible): Codes for the main intent of the study. |
| ||||||||
phase | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: ?? (extensible) | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: ?? (extensible) | |||||||||
category | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: ?? (extensible) | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: ?? (extensible) | |||||||||
focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: ?? (example): Codes for medications, devices and other interventions. | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: ?? (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: ?? (example): Identification of the condition or diagnosis. | SΣ | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by Binding: ?? (example): Identification of the condition or diagnosis. | |||||||||
contact | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) | |||||||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | ||||||||||
name | Σ | 0..1 | string | Name of an individual to contact | Σ | 0..1 | string | Name of an individual to contact | |||||||||
telecom | Σ | 0..* | ContactPoint | Contact details for individual or organization | ΣC | 0..* | ContactPoint | Contact details for individual or organization | |||||||||
relatedArtifact | 0..* | RelatedArtifact | References and dependencies | S | 0..* | RelatedArtifact | Publications et résumé des résultats / Publications about the study and Summary results |
| |||||||||
keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Words associated with the study that may be useful in discovery. | Σ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Words associated with the study that may be useful in discovery. | |||||||||
location | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. | |||||||||
description | S | 0..1 | markdown | Résumé de l'essai / Summary Results | S | 0..1 | markdown | Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results | |||||||||
enrollment | SΣ | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria | SΣC | 0..* | Reference(ECLAIREGroup) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria | |||||||||
period | Σ | 0..1 | Period | When the study began and ended | ΣC | 0..1 | Period | When the study began and ended | |||||||||
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 |
| ||||||||||||
start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| ||||||||||||
end | SΣC | 0..1 | dateTime | Date à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date |
| ||||||||||||
sponsor | SΣ | 0..1 | Reference(Organization) | Promoteur / primary Sponsor | ΣC | 0..0 |
| ||||||||||
principalInvestigator | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ΣC | 0..0 |
| ||||||||||
site | SΣ | 0..* | Reference(Location) | Lieux / Countries of Recruitment | SΣC | 0..* | Reference(ECLAIRELocation) | 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: ?? (example): Codes for why the study ended prematurely. | Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ?? (example): Codes for why the study ended prematurely. | |||||||||
note | 0..* | Annotation | Comments made about the study | 0..* | Annotation | Comments made about the study | |||||||||||
arm | 0..* | BackboneElement | Defined path through the study for a subject | 0..* | BackboneElement | Defined path through the study for a subject | |||||||||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
extension | 0..* | Extension | Additional content defined by implementations | 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 | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
name | 1..1 | string | Label for study arm | 1..1 | string | Label for study arm | |||||||||||
type | 0..1 | CodeableConcept | Categorization of study arm | 0..1 | CodeableConcept | Categorization of study arm | |||||||||||
description | 0..1 | string | Short explanation of study path | 0..1 | string | Short explanation of study path | |||||||||||
objective | 0..* | BackboneElement | A goal for the study | 0..* | BackboneElement | A goal for the study | |||||||||||
id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
extension | 0..* | Extension | Additional content defined by implementations | 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 | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
name | 0..1 | string | Label for the objective | 0..1 | string | Label for the objective | |||||||||||
type | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. | |||||||||||
Documentation for this format |