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Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
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Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.3.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ECLAIREResearchStudy

Official URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy Version: 0.3.1
Draft as of 2025-11-27 Computable Name: ECLAIREResearchStudy

Profil de ResearchStudy pour le projet ECLAIRE

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NomDrapeauxCard.TypeDescription et contraintes    Filter: Filtersdoco
.. 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
... Slices pour extension Content/Rules for all slices
.... extension: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
.... extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
.... extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
.... extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
.... extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
Binding: Statut de recrutement Value Set (extensible)
.... extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension: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
.... 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.
... primaryPurposeType SΣ 0..1 CodeableConcept Objectif principal / Primary purpose
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)
... Slices pour 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)
.... Slices pour extension Content/Rules for all slices
..... extension: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)
..... extension:eclaire-contact-address S 0..1 Address Adresse du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
..... extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
..... extension:eclaire-contact-name S 0..1 HumanName Nom du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name
... relatedArtifact S 0..* RelatedArtifact Publications et résumé des résultats / Publications about the study and Summary results
... 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 (description, durée de participation à l'essai clinique,etc) / Summary Results
... enrollment SΣC 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
Constraints: ref-1
... period ΣC 0..1 Period When the study began and ended
Constraints: per-1
.... 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
... site SΣC 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment
Constraints: ref-1
... arm 0..* BackboneElement Defined path through the study for a subject
.... Slices pour extension Content/Rules for all slices
..... extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string Label for study arm

doco Documentation for this format

Terminology Bindings

Path Statut Usage ValueSet Version Source
ResearchStudy.identifier:idPrimary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idSecondary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.0.1 FHIR Std.
ResearchStudy.phase Base extensible Value Set type de phase de l'essai clinique 📦0.3.1 cet IG
ResearchStudy.category Base extensible Value Set type pour spécifier la catégorie l'essai clinique 📦0.3.1 cet IG
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:medDRACondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:diseaseCondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.location Base extensible Jurisdiction 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **ALL** elements Must have either extensions or value[x], not both extension.exists() != value.exists()
per-1 error 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.enrollment, 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

NomDrapeauxCard.TypeDescription et contraintes    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... Slices pour extension Content/Rules for all slices
.... extension: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
.... extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
.... extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
.... extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
.... extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
Binding: Statut de recrutement Value Set (extensible)
.... extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension: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 pour identifier 0..* Identifier Business Identifier for study
Slice: Unordered, Open by value:use, value:system
.... 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
..... period
...... start 0..1 dateTime Date d'inscription au registre principal / Date of Registration in Primary Registry
.... 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
... primaryPurposeType S 0..1 CodeableConcept Objectif principal / Primary purpose
... 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 pour 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: https://www.meddra.org
.... 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)
.... Slices pour extension Content/Rules for all slices
..... extension: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)
..... extension:eclaire-contact-address S 0..1 Address Adresse du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
..... extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
..... extension:eclaire-contact-name S 0..1 HumanName Nom du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name
... relatedArtifact S 0..* RelatedArtifact Publications et résumé des résultats / Publications about the study and Summary results
... location S 0..* CodeableConcept Pays de recrutement / Countries of Recruitment
... description S 0..1 markdown Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results
... enrollment S 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
... period
.... end S 0..1 dateTime Date à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date
... sponsor 0..0 Organization that initiates and is legally responsible for the study
... principalInvestigator 0..0 Researcher who oversees multiple aspects of the study
... site S 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment
... arm
.... Slices pour extension Content/Rules for all slices
..... extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention

doco Documentation for this format

Terminology Bindings (Differential)

Path Statut Usage ValueSet Version Source
ResearchStudy.phase Base extensible Value Set type de phase de l'essai clinique 📦0.3.1 cet IG
ResearchStudy.category Base extensible Value Set type pour spécifier la catégorie l'essai clinique 📦0.3.1 cet IG
NomDrapeauxCard.TypeDescription et contraintes    Filter: Filtersdoco
.. 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.
Bindings AdditionnelsBut
AllLanguages Binding Max
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices pour extension N 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension: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
.... extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
.... extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
.... extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
.... extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
Binding: Statut de recrutement Value Set (extensible)
.... extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension: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 pour identifier Σ 0..* Identifier Business Identifier for study
Slice: Unordered, Open by value:use, value:system
.... 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
Exemple General: http://www.acme.com/identifiers/patient
..... value Σ 0..1 string The value that is unique
Exemple General: 123456
..... period ΣC 0..1 Period Time period when id is/was valid for use
Constraints: per-1
...... 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
...... start ΣC 0..1 dateTime Date d'inscription au registre principal / Date of Registration in Primary Registry
...... end ΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
..... assigner ΣC 0..1 Reference(Organization) Organization that issued id (may be just text)
Constraints: ref-1
.... 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
Exemple General: http://www.acme.com/identifiers/patient
..... value Σ 0..1 string The value that is unique
Exemple General: 123456
..... period ΣC 0..1 Period Time period when id is/was valid for use
Constraints: per-1
..... assigner ΣC 0..1 Reference(Organization) Organization that issued id (may be just text)
Constraints: ref-1
... title SΣ 0..1 string Nom scientifique de l'étude / Scientific Title
... protocol ΣC 0..* Reference(PlanDefinition) Steps followed in executing study
Constraints: ref-1
... partOf ΣC 0..* Reference(ResearchStudy) Part of larger study
Constraints: ref-1
... 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 SΣ 0..1 CodeableConcept Objectif principal / Primary purpose
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
Description du binding: (example): Codes for medications, devices and other interventions.
... Slices pour 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: https://www.meddra.org
...... 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 pour extension N 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension: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)
..... extension:eclaire-contact-address S 0..1 Address Adresse du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
..... extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
..... extension:eclaire-contact-name S 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
Constraints: cpt-2
... relatedArtifact 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
Description du binding: (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 (description, durée de participation à l'essai clinique,etc) / Summary Results
... enrollment SΣC 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
Constraints: ref-1
... period ΣC 0..1 Period When the study began and ended
Constraints: per-1
.... 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
.... 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
... site SΣC 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment
Constraints: ref-1
... 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
.... Slices pour extension N 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention
.... 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.

doco Documentation for this format

Terminology Bindings

Path Statut Usage ValueSet Version Source
ResearchStudy.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idPrimary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idPrimary.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idSecondary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idSecondary.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.0.1 FHIR Std.
ResearchStudy.phase Base extensible Value Set type de phase de l'essai clinique 📦0.3.1 cet IG
ResearchStudy.category Base extensible Value Set type pour spécifier la catégorie l'essai clinique 📦0.3.1 cet IG
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:medDRACondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:diseaseCondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.location Base extensible Jurisdiction 📍4.0.1 FHIR Std.
ResearchStudy.reasonStopped Base example ResearchStudyReasonStopped 📍4.0.1 FHIR Std.
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **ALL** elements 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.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

Résumé

Mandatory: 0 element(3 nested mandatory elements)
Must-Support: 31 elements
Prohibited: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 2 is sliced based on the values of ResearchStudy.identifier
  • There is a slice with no discriminator at ResearchStudy.condition

Key Elements View

NomDrapeauxCard.TypeDescription et contraintes    Filter: Filtersdoco
.. 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
... Slices pour extension Content/Rules for all slices
.... extension: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
.... extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
.... extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
.... extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
.... extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
Binding: Statut de recrutement Value Set (extensible)
.... extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension: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
.... 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.
... primaryPurposeType SΣ 0..1 CodeableConcept Objectif principal / Primary purpose
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)
... Slices pour 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)
.... Slices pour extension Content/Rules for all slices
..... extension: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)
..... extension:eclaire-contact-address S 0..1 Address Adresse du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
..... extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
..... extension:eclaire-contact-name S 0..1 HumanName Nom du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name
... relatedArtifact S 0..* RelatedArtifact Publications et résumé des résultats / Publications about the study and Summary results
... 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 (description, durée de participation à l'essai clinique,etc) / Summary Results
... enrollment SΣC 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
Constraints: ref-1
... period ΣC 0..1 Period When the study began and ended
Constraints: per-1
.... 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
... site SΣC 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment
Constraints: ref-1
... arm 0..* BackboneElement Defined path through the study for a subject
.... Slices pour extension Content/Rules for all slices
..... extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string Label for study arm

doco Documentation for this format

Terminology Bindings

Path Statut Usage ValueSet Version Source
ResearchStudy.identifier:idPrimary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idSecondary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.0.1 FHIR Std.
ResearchStudy.phase Base extensible Value Set type de phase de l'essai clinique 📦0.3.1 cet IG
ResearchStudy.category Base extensible Value Set type pour spécifier la catégorie l'essai clinique 📦0.3.1 cet IG
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:medDRACondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:diseaseCondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.location Base extensible Jurisdiction 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **ALL** elements Must have either extensions or value[x], not both extension.exists() != value.exists()
per-1 error 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.enrollment, 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'))

Differential View

This structure is derived from ResearchStudy

NomDrapeauxCard.TypeDescription et contraintes    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... Slices pour extension Content/Rules for all slices
.... extension: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
.... extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
.... extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
.... extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
.... extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
Binding: Statut de recrutement Value Set (extensible)
.... extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension: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 pour identifier 0..* Identifier Business Identifier for study
Slice: Unordered, Open by value:use, value:system
.... 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
..... period
...... start 0..1 dateTime Date d'inscription au registre principal / Date of Registration in Primary Registry
.... 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
... primaryPurposeType S 0..1 CodeableConcept Objectif principal / Primary purpose
... 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 pour 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: https://www.meddra.org
.... 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)
.... Slices pour extension Content/Rules for all slices
..... extension: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)
..... extension:eclaire-contact-address S 0..1 Address Adresse du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
..... extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
..... extension:eclaire-contact-name S 0..1 HumanName Nom du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name
... relatedArtifact S 0..* RelatedArtifact Publications et résumé des résultats / Publications about the study and Summary results
... location S 0..* CodeableConcept Pays de recrutement / Countries of Recruitment
... description S 0..1 markdown Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results
... enrollment S 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
... period
.... end S 0..1 dateTime Date à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date
... sponsor 0..0 Organization that initiates and is legally responsible for the study
... principalInvestigator 0..0 Researcher who oversees multiple aspects of the study
... site S 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment
... arm
.... Slices pour extension Content/Rules for all slices
..... extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention

doco Documentation for this format

Terminology Bindings (Differential)

Path Statut Usage ValueSet Version Source
ResearchStudy.phase Base extensible Value Set type de phase de l'essai clinique 📦0.3.1 cet IG
ResearchStudy.category Base extensible Value Set type pour spécifier la catégorie l'essai clinique 📦0.3.1 cet IG

Snapshot View

NomDrapeauxCard.TypeDescription et contraintes    Filter: Filtersdoco
.. 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.
Bindings AdditionnelsBut
AllLanguages Binding Max
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices pour extension N 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... extension: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
.... extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
.... extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
.... extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
.... extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
Binding: Statut de recrutement Value Set (extensible)
.... extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
.... extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
.... extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
.... extension: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 pour identifier Σ 0..* Identifier Business Identifier for study
Slice: Unordered, Open by value:use, value:system
.... 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
Exemple General: http://www.acme.com/identifiers/patient
..... value Σ 0..1 string The value that is unique
Exemple General: 123456
..... period ΣC 0..1 Period Time period when id is/was valid for use
Constraints: per-1
...... 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
...... start ΣC 0..1 dateTime Date d'inscription au registre principal / Date of Registration in Primary Registry
...... end ΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
..... assigner ΣC 0..1 Reference(Organization) Organization that issued id (may be just text)
Constraints: ref-1
.... 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
Exemple General: http://www.acme.com/identifiers/patient
..... value Σ 0..1 string The value that is unique
Exemple General: 123456
..... period ΣC 0..1 Period Time period when id is/was valid for use
Constraints: per-1
..... assigner ΣC 0..1 Reference(Organization) Organization that issued id (may be just text)
Constraints: ref-1
... title SΣ 0..1 string Nom scientifique de l'étude / Scientific Title
... protocol ΣC 0..* Reference(PlanDefinition) Steps followed in executing study
Constraints: ref-1
... partOf ΣC 0..* Reference(ResearchStudy) Part of larger study
Constraints: ref-1
... 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 SΣ 0..1 CodeableConcept Objectif principal / Primary purpose
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
Description du binding: (example): Codes for medications, devices and other interventions.
... Slices pour 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: https://www.meddra.org
...... 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 pour extension N 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension: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)
..... extension:eclaire-contact-address S 0..1 Address Adresse du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
..... extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
..... extension:eclaire-contact-name S 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
Constraints: cpt-2
... relatedArtifact 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
Description du binding: (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 (description, durée de participation à l'essai clinique,etc) / Summary Results
... enrollment SΣC 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
Constraints: ref-1
... period ΣC 0..1 Period When the study began and ended
Constraints: per-1
.... 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
.... 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
... site SΣC 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment
Constraints: ref-1
... 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
.... Slices pour extension N 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention
.... 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.

doco Documentation for this format

Terminology Bindings

Path Statut Usage ValueSet Version Source
ResearchStudy.language Base preferred Common Languages 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idPrimary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idPrimary.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idSecondary.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
ResearchStudy.identifier:idSecondary.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
ResearchStudy.status Base required ResearchStudyStatus 📍4.0.1 FHIR Std.
ResearchStudy.primaryPurposeType Base extensible ResearchStudyPrimaryPurposeType 📍4.0.1 FHIR Std.
ResearchStudy.phase Base extensible Value Set type de phase de l'essai clinique 📦0.3.1 cet IG
ResearchStudy.category Base extensible Value Set type pour spécifier la catégorie l'essai clinique 📦0.3.1 cet IG
ResearchStudy.focus Base example Not State Unknown
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:medDRACondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.condition:diseaseCondition Base example Condition/Problem/Diagnosis Codes 📍4.0.1 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.location Base extensible Jurisdiction 📍4.0.1 FHIR Std.
ResearchStudy.reasonStopped Base example ResearchStudyReasonStopped 📍4.0.1 FHIR Std.
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 **ALL** elements 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.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

Résumé

Mandatory: 0 element(3 nested mandatory elements)
Must-Support: 31 elements
Prohibited: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 2 is sliced based on the values of ResearchStudy.identifier
  • There is a slice with no discriminator at ResearchStudy.condition

 

Other representations of profile: CSV, Excel, Schematron