{ "resourceType": "ResearchStudy", "id": "fake-study-example", "meta": { "profile": [ "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy" ] }, "text": { "status": "extensions", "div": "

Generated Narrative: ResearchStudy

Resource ResearchStudy "fake-study-example"

Profile: ECLAIREResearchStudy

ECLAIREReviewDate: Jan 6, 2023, 12:00:00 AM

ECLAIREApprovalDate: Mar 6, 2023, 12:00:00 AM

ECLAIRETherapeuticArea: domaine thérapeutique z

ECLAIRERecruitmentPeriod: 2022-06-30 00:00:00+0000 --> (ongoing)

ECLAIRERecruitmentStatus: Actif / active (Statut de recrutement#recruiting)

Extension Definition for ResearchStudy.descriptionSummary for Version 5.0: Ceci est un test de ressource pour Eclaire

ECLAIREoutcomeMeasureR5

url

value

value: Nom de la conséquence primaire

url

type

value: primaire (ResearchStudyObjectiveType#primary)

url

description

value: Description de la conséquence primaire

url

description

value: EvidenceVariable/1: Aïe!

ECLAIREoutcomeMeasureR5

url

value

value: Nom de la conséquence secondaire

url

type

value: secondaire (ResearchStudyObjectiveType#secondary)

url

description

value: Description de la conséquence secondaire

url

description

value: EvidenceVariable/1: Ouille!

ECLAIREassociatedPartyR5

url

name

value: THE sponsor

url

role

value: Sponsor principal (Définition des rôles des parties prenantes inspiré de http://hl7.org/fhir/research-study-party-role#lead-sponsor)

url

period

value: 2022-06-30 00:00:00+0000 --> (ongoing)

url

classifier

value: academic (Définition des différents types d'organisation des parties prenantes inspiré de http://hl7.org/fhir/research-study-party-organization-type#academic)

url

party

value: Organization/2: Etablissement du sponsor

ECLAIRELabelR5

url

value

value: INDISPONIBLE

url

type

value: type (Définition des types de titre pour l'essai#human-use)

ECLAIRELabelR5

url

value

value: INDISPONIBLE

url

type

value: type (Définition des types de titre pour l'essai#acronym)

identifier: Hilarious Cat/123456 (use: OFFICIAL), 2022-500014-26-00 (use: SECONDARY)

title: Energetic Zebra

protocol: PlanDefinition/3: Energetic plan

status: in-review

primaryPurposeType: Zebra treatment (ResearchStudyPrimaryPurposeType[4.0.1]#treatment)

phase: Research Study Phase (ResearchStudyPhase#phase-3)

category: IC-Cas 1 (DM) (Précision sur la réglementation concernant l'essai#IC-Cas-1)

focus: Hilarious medicament ()

condition: Locally-Advanced or Metastatic breast cancer (MBC) (), MedDRA condition code 10070575 (mdr#10070575 "10070575")

contact: Slow Zebra: ph: Energetic Zebra(WORK),ph: Energetic Badger(HOME)

keyword: Fast Elephant ()

location: Countries of recruitment (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code[4.0.1]#FR)

description: This is a fake research study

enrollment: Group/6: Fast Zebra

site: Location/8: Rainbow

reasonStopped: ouch (ResearchStudyReasonStopped[4.0.1]#closed-due-to-toxicity)

Arms

-ExtensionNameDescription
*Slow ElephantHilarious Badger

Objectives

-Name
*Inventive Mouse
" }, "extension": [ { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date", "valueInstant": "2023-01-06T00:00:00Z" }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date", "valueInstant": "2023-03-06T00:00:00Z" }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area", "valueString": "domaine thérapeutique z" }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period", "valuePeriod": { "start": "2022-06-30T00:00:00Z" } }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status", "valueCodeableConcept": { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-status-recruitment-code-system", "code": "recruiting" } ] } }, { "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary", "valueMarkdown": "Ceci est un test de ressource pour Eclaire" }, { "extension": [ { "url": "value", "valueString": "Nom de la conséquence primaire" }, { "url": "type", "valueCodeableConcept": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type", "code": "primary" } ], "text": "primaire" } }, { "url": "description", "valueMarkdown": "Description de la conséquence primaire" }, { "url": "description", "valueReference": { "reference": "EvidenceVariable/1", "display": "Aïe!" } } ], "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure" }, { "extension": [ { "url": "value", "valueString": "Nom de la conséquence secondaire" }, { "url": "type", "valueCodeableConcept": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type", "code": "secondary" } ], "text": "secondaire" } }, { "url": "description", "valueMarkdown": "Description de la conséquence secondaire" }, { "url": "description", "valueReference": { "reference": "EvidenceVariable/1", "display": "Ouille!" } } ], "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure" }, { "extension": [ { "url": "name", "valueString": "THE sponsor" }, { "url": "role", "valueCodeableConcept": { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-party-role-code-system", "code": "lead-sponsor" } ], "text": "Sponsor principal" } }, { "url": "period", "valuePeriod": { "start": "2022-06-30T00:00:00Z" } }, { "url": "classifier", "valueCodeableConcept": { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-party-organization-type-code-system", "code": "academic" } ], "text": "academic" } }, { "url": "party", "valueReference": { "reference": "Organization/2", "display": "Etablissement du sponsor" } } ], "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty" }, { "extension": [ { "url": "value", "valueString": "INDISPONIBLE" }, { "url": "type", "valueCodeableConcept": { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-title-type-code-system", "code": "human-use" } ], "text": "type" } } ], "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label" }, { "extension": [ { "url": "value", "valueString": "INDISPONIBLE" }, { "url": "type", "valueCodeableConcept": { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-title-type-code-system", "code": "acronym" } ], "text": "type" } } ], "url": "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label" } ], "identifier": [ { "use": "official", "type": { "text": "Hilarious Cat" }, "value": "123456", "assigner": { "reference": "Organization/1", "display": "Crazy Mouse" } }, { "use": "secondary", "value": "2022-500014-26-00", "assigner": { "reference": "Organization/ctis", "type": "Organization", "display": "Reference to secondary assigner" } } ], "title": "Energetic Zebra", "protocol": [ { "reference": "PlanDefinition/3", "display": "Energetic plan" } ], "status": "in-review", "primaryPurposeType": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type", "version": "4.0.1", "code": "treatment" } ], "text": "Zebra treatment" }, "phase": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/research-study-phase", "code": "phase-3" } ], "text": "Research Study Phase" }, "category": [ { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-reglementation-precision-code-system", "code": "IC-Cas-1" } ] } ], "focus": [ { "text": "Hilarious medicament" } ], "condition": [ { "text": "Locally-Advanced or Metastatic breast cancer (MBC)" }, { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/mdr", "code": "10070575", "display": "10070575" } ], "text": "MedDRA condition code 10070575" } ], "contact": [ { "extension": [ { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type", "valueCodeableConcept": { "coding": [ { "system": "https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-type-contact-code-system", "code": "PUB" } ], "text": "Publique / Public" } }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address", "valueAddress": { "use": "home", "type": "physical", "text": "137 Nowhere Street, Erewhon 9132", "line": [ "137 Nowhere Street" ], "city": "Erewhon", "district": "Madison", "state": "Fantastic Badger", "postalCode": "9132", "country": "Crazy Elephant" } }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation", "valueString": "Hilarious Badger" }, { "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name", "valueHumanName": { "use": "usual", "text": "Inventive Mouse", "family": "Fantastic Zebra", "given": [ "Energetic Cat" ], "prefix": [ "Fantastic Zebra" ], "suffix": [ "Crazy Elephant" ] } } ], "name": "Slow Zebra", "telecom": [ { "system": "phone", "value": "Energetic Zebra", "use": "work" }, { "system": "phone", "value": "Energetic Badger", "use": "home" } ] } ], "keyword": [ { "text": "Fast Elephant" } ], "location": [ { "coding": [ { "system": "urn:iso:std:iso:3166", "version": "4.0.1", "code": "FR" } ], "text": "Countries of recruitment" } ], "description": "This is a fake research study", "enrollment": [ { "reference": "Group/6", "display": "Fast Zebra" } ], "site": [ { "reference": "Location/8", "display": "Rainbow" } ], "reasonStopped": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/research-study-reason-stopped", "version": "4.0.1", "code": "closed-due-to-toxicity" } ], "text": "ouch" }, "arm": [ { "extension": [ { "extension": [ { "url": "name", "valueString": "Nom de l'intervention" }, { "url": "description", "valueString": "Description de l'intervention" } ], "url": "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention" } ], "name": "Slow Elephant", "description": "Hilarious Badger" } ], "objective": [ { "name": "Inventive Mouse" } ] }