Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.3.0 - trial-use
Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.3.0 - trial-use
Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.3.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
{
"resourceType" : "ResearchStudy",
"id" : "fake-study-example",
"meta" : {
"profile" : [
🔗 "https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"fake-study-example\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ResearchStudy "fake-study-example" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-eclaire-researchstudy.html\">ECLAIREResearchStudy</a></p></div><p><b>ECLAIREReviewDate</b>: Jan 6, 2023, 12:00:00 AM</p><p><b>ECLAIREApprovalDate</b>: Mar 6, 2023, 12:00:00 AM</p><p><b>ECLAIRETherapeuticArea</b>: domaine thérapeutique z</p><p><b>ECLAIRERecruitmentPeriod</b>: 2022-06-30 00:00:00+0000 --> (ongoing)</p><p><b>ECLAIRERecruitmentStatus</b>: Actif / active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-eclaire-status-recruitment-code-system.html\">Statut de recrutement</a>#recruiting)</span></p><p><b>Extension Definition for ResearchStudy.descriptionSummary for Version 5.0</b>: Ceci est un test de ressource pour Eclaire</p><blockquote><p><b>ECLAIREoutcomeMeasureR5</b></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: Nom de la conséquence primaire</p><blockquote><p><b>url</b></p><code>type</code></blockquote><p><b>value</b>: primaire <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p><blockquote><p><b>url</b></p><code>description</code></blockquote><p><b>value</b>: Description de la conséquence primaire</p><blockquote><p><b>url</b></p><code>description</code></blockquote><p><b>value</b>: <a href=\"EvidenceVariable/1\">EvidenceVariable/1: Aïe!</a></p></blockquote><blockquote><p><b>ECLAIREoutcomeMeasureR5</b></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: Nom de la conséquence secondaire</p><blockquote><p><b>url</b></p><code>type</code></blockquote><p><b>value</b>: secondaire <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p><blockquote><p><b>url</b></p><code>description</code></blockquote><p><b>value</b>: Description de la conséquence secondaire</p><blockquote><p><b>url</b></p><code>description</code></blockquote><p><b>value</b>: <a href=\"EvidenceVariable/1\">EvidenceVariable/1: Ouille!</a></p></blockquote><blockquote><p><b>ECLAIREassociatedPartyR5</b></p><blockquote><p><b>url</b></p><code>name</code></blockquote><p><b>value</b>: THE sponsor</p><blockquote><p><b>url</b></p><code>role</code></blockquote><p><b>value</b>: Sponsor principal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-eclaire-study-party-role-code-system.html\">Définition des rôles des parties prenantes inspiré de http://hl7.org/fhir/research-study-party-role</a>#lead-sponsor)</span></p><blockquote><p><b>url</b></p><code>period</code></blockquote><p><b>value</b>: 2022-06-30 00:00:00+0000 --> (ongoing)</p><blockquote><p><b>url</b></p><code>classifier</code></blockquote><p><b>value</b>: academic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-eclaire-study-party-organization-type-code-system.html\">Définition des différents types d'organisation des parties prenantes inspiré de http://hl7.org/fhir/research-study-party-organization-type</a>#academic)</span></p><blockquote><p><b>url</b></p><code>party</code></blockquote><p><b>value</b>: <a href=\"Organization/2\">Organization/2: Etablissement du sponsor</a></p></blockquote><blockquote><p><b>ECLAIRELabelR5</b></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: INDISPONIBLE</p><blockquote><p><b>url</b></p><code>type</code></blockquote><p><b>value</b>: type <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-eclaire-study-title-type-code-system.html\">Définition des types de titre pour l'essai</a>#human-use)</span></p></blockquote><blockquote><p><b>ECLAIRELabelR5</b></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: INDISPONIBLE</p><blockquote><p><b>url</b></p><code>type</code></blockquote><p><b>value</b>: type <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-eclaire-study-title-type-code-system.html\">Définition des types de titre pour l'essai</a>#acronym)</span></p></blockquote><p><b>identifier</b>: Hilarious Cat/123456\u00a0(use:\u00a0OFFICIAL), 2022-500014-26-00\u00a0(use:\u00a0SECONDARY)</p><p><b>title</b>: Energetic Zebra</p><p><b>protocol</b>: <a href=\"PlanDefinition/3\">PlanDefinition/3: Energetic plan</a></p><p><b>status</b>: in-review</p><p><b>primaryPurposeType</b>: Zebra treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ResearchStudyPrimaryPurposeType[4.0.1]#treatment)</span></p><p><b>phase</b>: Research Study Phase <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-3)</span></p><p><b>category</b>: IC-Cas 1 (DM) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-eclaire-reglementation-precision-code-system.html\">Précision sur la réglementation concernant l'essai</a>#IC-Cas-1)</span></p><p><b>focus</b>: Hilarious medicament <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>condition</b>: Locally-Advanced or Metastatic breast cancer (MBC) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span>, MedDRA condition code 10070575 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (mdr#10070575 "10070575")</span></p><p><b>contact</b>: Slow Zebra: ph: Energetic Zebra(WORK),ph: Energetic Badger(HOME)</p><p><b>keyword</b>: Fast Elephant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>location</b>: Countries of recruitment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code[4.0.1]#FR)</span></p><p><b>description</b>: This is a fake research study</p><p><b>enrollment</b>: <a href=\"Group/6\">Group/6: Fast Zebra</a></p><p><b>site</b>: <a href=\"Location/8\">Location/8: Rainbow</a></p><p><b>reasonStopped</b>: ouch <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ResearchStudyReasonStopped[4.0.1]#closed-due-to-toxicity)</span></p><h3>Arms</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>Name</b></td><td><b>Description</b></td></tr><tr><td style=\"display: none\">*</td><td/><td>Slow Elephant</td><td>Hilarious Badger</td></tr></table><h3>Objectives</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Inventive Mouse</td></tr></table></div>"
},
"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" : "2022-06-30T00:00:00.000Z"
}
},
{
"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" : "2022-06-30T00:00:00.000Z"
}
},
{
"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"
}
]
}