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-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
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-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)
eclaire-description-summary-r5	S	0..1	markdown	Texte bref décrivant l'essai / Brief text explaining the study. URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
value[x]		1..1	markdown	Value of 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
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
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
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
status	S	1..1	code	Statut de l'essai / Study Status
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 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	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
principalInvestigator		0..0
site	S	0..*	Reference(ECLAIRELocation)	Lieux / Countries of Recruitment
arm
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ResearchStudy.phase	extensible	EclaireStudyPhaseVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs from this IG
ResearchStudy.category	extensible	EclaireCategoryVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs from this IG

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-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
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-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)
eclaire-description-summary-r5	S	0..1	markdown	Texte bref décrivant l'essai / Brief text explaining the study. URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary"
value[x]		1..1	markdown	Value of 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
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
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.
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 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	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
period	ΣC	0..1	Period	When the study began and ended
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
arm		0..*	BackboneElement	Defined path through the study for a subject
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ResearchStudy.identifier:idPrimary.use	required	Pattern: official http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:idSecondary.use	required	Pattern: secondary http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	extensible	EclaireStudyPhaseVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs from this IG
ResearchStudy.category	extensible	EclaireCategoryVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs from this IG
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:medDRACondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:diseaseCondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard

Constraints

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	**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'))

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. Additional Bindings Purpose AllLanguages Max Binding
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-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
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-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)
eclaire-description-summary-r5	S	0..1	markdown	Texte bref décrivant l'essai / Brief text explaining the study. URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary"
value[x]		1..1	markdown	Value of 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
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
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
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)
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	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 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	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
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 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 (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
period	ΣC	0..1	Period	When the study began and ended
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
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 for extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ResearchStudy.identifier:idPrimary.use	required	Pattern: official http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:idPrimary.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchStudy.identifier:idSecondary.use	required	Pattern: secondary http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:idSecondary.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	extensible	EclaireStudyPhaseVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs from this IG
ResearchStudy.category	extensible	EclaireCategoryVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs from this IG
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:medDRACondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:diseaseCondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard

Constraints

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	**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'))

Summary

Mandatory: 0 element (4 nested mandatory elements)
Must-Support: 31 elements
Prohibited: 2 elements

Structures

This structure refers to these other structures:

• ECLAIREGroup (https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-group)
• ECLAIRELocation (https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-location)

Extensions

This structure refers to these extensions:

• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status
• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure
• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name
• https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention

Slices

This structure defines the following Slices:

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

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-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
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-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)
eclaire-description-summary-r5	S	0..1	markdown	Texte bref décrivant l'essai / Brief text explaining the study. URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
value[x]		1..1	markdown	Value of 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
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
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
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
status	S	1..1	code	Statut de l'essai / Study Status
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 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	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
principalInvestigator		0..0
site	S	0..*	Reference(ECLAIRELocation)	Lieux / Countries of Recruitment
arm
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ResearchStudy.phase	extensible	EclaireStudyPhaseVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs from this IG
ResearchStudy.category	extensible	EclaireCategoryVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs from this IG

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-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
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-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)
eclaire-description-summary-r5	S	0..1	markdown	Texte bref décrivant l'essai / Brief text explaining the study. URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary"
value[x]		1..1	markdown	Value of 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
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
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.
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 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	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
period	ΣC	0..1	Period	When the study began and ended
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
arm		0..*	BackboneElement	Defined path through the study for a subject
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ResearchStudy.identifier:idPrimary.use	required	Pattern: official http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:idSecondary.use	required	Pattern: secondary http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	extensible	EclaireStudyPhaseVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs from this IG
ResearchStudy.category	extensible	EclaireCategoryVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs from this IG
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:medDRACondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:diseaseCondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard

Constraints

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	**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'))

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. Additional Bindings Purpose AllLanguages Max Binding
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-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
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-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)
eclaire-description-summary-r5	S	0..1	markdown	Texte bref décrivant l'essai / Brief text explaining the study. URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary"
value[x]		1..1	markdown	Value of 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
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
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
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)
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	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 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	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
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 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 (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
period	ΣC	0..1	Period	When the study began and ended
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
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 for extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ResearchStudy.identifier:idPrimary.use	required	Pattern: official http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:idPrimary.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchStudy.identifier:idSecondary.use	required	Pattern: secondary http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:idSecondary.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	extensible	EclaireStudyPhaseVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs from this IG
ResearchStudy.category	extensible	EclaireCategoryVS https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs from this IG
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:medDRACondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.condition:diseaseCondition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard

Constraints

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	**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'))