This is the set of resources that conform to either of the profiles ECLAIREResearchStudy (https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy) and ECLAIREResearchStudy (https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy). E.g. what you have to deal with if you get resources conforming to one of them
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ResearchStudy | 0..* | 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 | ||
meta | Σ | 0..1 | Meta | Metadata about the resource ele-1: All FHIR elements must have a @value or children |
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 |
language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language. ele-1: All FHIR elements must have a @value or children | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation ele-1: All FHIR elements must have a @value or children | |
contained | 0..* | Resource | Contained, inline Resources | |
extension | 0..* | Extension | left: Extension; right: Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
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 | 0..* | Identifier | Business Identifier for study ele-1: All FHIR elements must have a @value or children |
title | SΣ | 0..1 | string | Nom scientifique de l'étude / Scientific Title ele-1: All FHIR elements must have a @value or children |
protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study ele-1: All FHIR elements must have a @value or children |
partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study ele-1: All FHIR elements must have a @value or children |
status | ?!SΣ | 1..1 | code | Statut de l'essai / Study Status Binding: ?? (required): Codes that convey the current status of the research study. ele-1: All FHIR elements must have a @value or children |
primaryPurposeType | SΣ | 0..1 | CodeableConcept | left: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility; right: Objectif principal / Primary purpose Binding: ?? (extensible): Codes for the main intent of the study. ele-1: All FHIR elements must have a @value or children |
phase | SΣ | 0..1 | CodeableConcept | Phase de l'essai / Study type : phase Binding: ?? (extensible) ele-1: All FHIR elements must have a @value or children |
category | SΣ | 0..* | CodeableConcept | Type d'essai / Study type : type of study Binding: ?? (extensible) ele-1: All FHIR elements must have a @value or children |
focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: ?? (example): Codes for medications, devices and other interventions. ele-1: All FHIR elements must have a @value or children |
condition | SΣ | 0..* | CodeableConcept | Sujet concerné / Problem(s) Studied exemple code MedDRA Binding: ?? (example): Identification of the condition or diagnosis. ele-1: All FHIR elements must have a @value or children |
contact | SΣ | 0..* | ContactDetail | Contact (Contact for public / scientific queries) ele-1: All FHIR elements must have a @value or children |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
name | Σ | 0..1 | string | Name of an individual to contact ele-1: All FHIR elements must have a @value or children |
telecom | Σ | 0..* | ContactPoint | Contact details for individual or organization ele-1: All FHIR elements must have a @value or children |
relatedArtifact | S | 0..* | RelatedArtifact | left: References and dependencies; right: Publications et résumé des résultats / Publications about the study and Summary results ele-1: All FHIR elements must have a @value or children |
keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Words associated with the study that may be useful in discovery. ele-1: All FHIR elements must have a @value or children |
location | SΣ | 0..* | CodeableConcept | Pays de recrutement / Countries of Recruitment Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. ele-1: All FHIR elements must have a @value or children |
description | S | 0..1 | markdown | left: Résumé de l'essai / Summary Results; right: Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results ele-1: All FHIR elements must have a @value or children |
enrollment | SΣ | 0..* | Reference(Group) | Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria ele-1: All FHIR elements must have a @value or children |
period | Σ | 0..1 | Period | When the study began and ended ele-1: All FHIR elements must have a @value or children |
extension | N | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary ele-1: All FHIR elements must have a @value or children |
end | SΣC | 0..1 | dateTime | Date à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date ele-1: All FHIR elements must have a @value or children |
sponsor | SΣ | 0..1 | Reference(Organization) | left: Promoteur / primary Sponsor; right: Organization that initiates and is legally responsible for the study ele-1: All FHIR elements must have a @value or children |
principalInvestigator | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study ele-1: All FHIR elements must have a @value or children |
site | SΣ | 0..* | Reference(Location) | Lieux / Countries of Recruitment ele-1: All FHIR elements must have a @value or children |
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. ele-1: All FHIR elements must have a @value or children |
note | 0..* | Annotation | Comments made about the study ele-1: All FHIR elements must have a @value or children | |
arm | 0..* | BackboneElement | Defined path through the study for a subject ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
name | 1..1 | string | Label for study arm ele-1: All FHIR elements must have a @value or children | |
type | 0..1 | CodeableConcept | Categorization of study arm ele-1: All FHIR elements must have a @value or children | |
description | 0..1 | string | Short explanation of study path ele-1: All FHIR elements must have a @value or children | |
objective | 0..* | BackboneElement | A goal for the study ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
name | 0..1 | string | Label for the objective ele-1: All FHIR elements must have a @value or children | |
type | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. ele-1: All FHIR elements must have a @value or children | |
Documentation for this format |