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
<ResearchStudy xmlns="http://hl7.org/fhir">
<id value="fake-study-example"/>
<meta>
<profile
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-researchstudy"/>
</meta>
<text>
<status value="extensions"/>
<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 (use: OFFICIAL), 2022-500014-26-00 (use: SECONDARY)</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>
</text>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date">
<valueInstant value="2023-01-06T00:00:00Z"/>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date">
<valueInstant value="2023-03-06T00:00:00Z"/>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area">
<valueString value="domaine thérapeutique z"/>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period">
<valuePeriod>
<start value="2022-06-30T00:00:00.000Z"/>
</valuePeriod>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status">
<valueCodeableConcept>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-status-recruitment-code-system"/>
<code value="recruiting"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary">
<valueMarkdown value="Ceci est un test de ressource pour Eclaire"/>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure">
<extension url="value">
<valueString value="Nom de la conséquence primaire"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
</coding>
<text value="primaire"/>
</valueCodeableConcept>
</extension>
<extension url="description">
<valueMarkdown value="Description de la conséquence primaire"/>
</extension>
<extension url="description">
<valueReference>
<reference value="EvidenceVariable/1"/>
<display value="Aïe!"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure">
<extension url="value">
<valueString value="Nom de la conséquence secondaire"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
</coding>
<text value="secondaire"/>
</valueCodeableConcept>
</extension>
<extension url="description">
<valueMarkdown value="Description de la conséquence secondaire"/>
</extension>
<extension url="description">
<valueReference>
<reference value="EvidenceVariable/1"/>
<display value="Ouille!"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty">
<extension url="name">
<valueString value="THE sponsor"/>
</extension>
<extension url="role">
<valueCodeableConcept>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-party-role-code-system"/>
<code value="lead-sponsor"/>
</coding>
<text value="Sponsor principal"/>
</valueCodeableConcept>
</extension>
<extension url="period">
<valuePeriod>
<start value="2022-06-30T00:00:00.000Z"/>
</valuePeriod>
</extension>
<extension url="classifier">
<valueCodeableConcept>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-party-organization-type-code-system"/>
<code value="academic"/>
</coding>
<text value="academic"/>
</valueCodeableConcept>
</extension>
<extension url="party">
<valueReference>
<reference value="Organization/2"/>
<display value="Etablissement du sponsor"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
<extension url="value">
<valueString value="INDISPONIBLE"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-title-type-code-system"/>
<code value="human-use"/>
</coding>
<text value="type"/>
</valueCodeableConcept>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
<extension url="value">
<valueString value="INDISPONIBLE"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-title-type-code-system"/>
<code value="acronym"/>
</coding>
<text value="type"/>
</valueCodeableConcept>
</extension>
</extension>
<identifier>
<use value="official"/>
<type>
<text value="Hilarious Cat"/>
</type>
<value value="123456"/>
<assigner>
<reference value="Organization/1"/>
<display value="Crazy Mouse"/>
</assigner>
</identifier>
<identifier>
<use value="secondary"/>
<value value="2022-500014-26-00"/>
<assigner>
<reference value="Organization/ctis"/>
<type value="Organization"/>
<display value="Reference to secondary assigner"/>
</assigner>
</identifier>
<title value="Energetic Zebra"/>
<protocol>
<reference value="PlanDefinition/3"/>
<display value="Energetic plan"/>
</protocol>
<status value="in-review"/>
<primaryPurposeType>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
<version value="4.0.1"/>
<code value="treatment"/>
</coding>
<text value="Zebra treatment"/>
</primaryPurposeType>
<phase>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
<code value="phase-3"/>
</coding>
<text value="Research Study Phase"/>
</phase>
<category>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-reglementation-precision-code-system"/>
<code value="IC-Cas-1"/>
</coding>
</category>
<focus>
<text value="Hilarious medicament"/>
</focus>
<condition>
<text value="Locally-Advanced or Metastatic breast cancer (MBC)"/>
</condition>
<condition>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/mdr"/>
<code value="10070575"/>
<display value="10070575"/>
</coding>
<text value="MedDRA condition code 10070575"/>
</condition>
<contact>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type">
<valueCodeableConcept>
<coding>
<system
value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-type-contact-code-system"/>
<code value="PUB"/>
</coding>
<text value="Publique / Public"/>
</valueCodeableConcept>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address">
<valueAddress>
<use value="home"/>
<type value="physical"/>
<text value="137 Nowhere Street, Erewhon 9132"/>
<line value="137 Nowhere Street"/>
<city value="Erewhon"/>
<district value="Madison"/>
<state value="Fantastic Badger"/>
<postalCode value="9132"/>
<country value="Crazy Elephant"/>
</valueAddress>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation">
<valueString value="Hilarious Badger"/>
</extension>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name">
<valueHumanName>
<use value="usual"/>
<text value="Inventive Mouse"/>
<family value="Fantastic Zebra"/>
<given value="Energetic Cat"/>
<prefix value="Fantastic Zebra"/>
<suffix value="Crazy Elephant"/>
</valueHumanName>
</extension>
<name value="Slow Zebra"/>
<telecom>
<system value="phone"/>
<value value="Energetic Zebra"/>
<use value="work"/>
</telecom>
<telecom>
<system value="phone"/>
<value value="Energetic Badger"/>
<use value="home"/>
</telecom>
</contact>
<keyword>
<text value="Fast Elephant"/>
</keyword>
<location>
<coding>
<system value="urn:iso:std:iso:3166"/>
<version value="4.0.1"/>
<code value="FR"/>
</coding>
<text value="Countries of recruitment"/>
</location>
<description value="This is a fake research study"/>
<enrollment>
<reference value="Group/6"/>
<display value="Fast Zebra"/>
</enrollment>
<site>
<reference value="Location/8"/>
<display value="Rainbow"/>
</site>
<reasonStopped>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-reason-stopped"/>
<version value="4.0.1"/>
<code value="closed-due-to-toxicity"/>
</coding>
<text value="ouch"/>
</reasonStopped>
<arm>
<extension
url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention">
<extension url="name">
<valueString value="Nom de l'intervention"/>
</extension>
<extension url="description">
<valueString value="Description de l'intervention"/>
</extension>
</extension>
<name value="Slow Elephant"/>
<description value="Hilarious Badger"/>
</arm>
<objective>
<name value="Inventive Mouse"/>
</objective>
</ResearchStudy>