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

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: UNE ETUDE DE PHASE III, RANDOMISEE, OUVERTE, EVALUANT L'EFFICACITE ET LA SECURITE DU GIREDESTRANT EN ASSOCIATION AVEC PHESGO. - XML Representation

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<ResearchStudy xmlns="http://hl7.org/fhir">
  <id value="2022-500014-26-00-example"/>
  <meta>
    <lastUpdated value="2024-05-31T00:00:00.000Z"/>
    <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 class="res-header-id"><b>Narratif généré : ResearchStudy 2022-500014-26-00-example</b></p><a name="2022-500014-26-00-example"> </a><a name="hc2022-500014-26-00-example"> </a><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">Dernière mise à jour : 2024-05-31 00:00:00+0000</p><p style="margin-bottom: 0px">Profil: <a href="StructureDefinition-eclaire-researchstudy.html">ECLAIREResearchStudy</a></p></div><blockquote><p><b>ECLAIREassociatedPartyR5</b></p><ul><li>name: THE sponsor</li><li>role: <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-party-role-code-system lead-sponsor}">Sponsor principal</span></li><li>period: 2022-06-30 00:00:00+0000 --&gt; (en cours)</li><li>classifier: <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-party-organization-type-code-system academic}">academic</span></li><li>party: <a href="Organization/2022-500014-26-00-secondary-sponsor">Reference to secondary sponsor</a></li></ul></blockquote><p><b>ECLAIRETherapeuticArea</b>: Maladies [C] - Tumeurs [C04]</p><blockquote><p><b>ECLAIRELabelR5</b></p><ul><li>type: <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-title-type-code-system human-use}">type</span></li></ul></blockquote><blockquote><p><b>ECLAIRELabelR5</b></p><ul><li>type: <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-study-title-type-code-system acronym}">type</span></li></ul></blockquote><p><b>ECLAIRERecruitmentPeriod</b>: 2022-06-30 00:00:00+0000 --&gt; (en cours)</p><p><b>ECLAIREReviewDate</b>: 2024-05-31 00:00:00+0000</p><p><b>ECLAIRERecruitmentStatus</b>: <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-status-recruitment-code-system recruiting}">Actif / active</span></p><p><b>ECLAIREDescriptionSummaryR5</b>: </p><div><p>Ceci est un test de ressource pour Eclaire</p>
</div><p><b>identifier</b>: <code>https://euclinicaltrials.eu</code>/2022-500014-26-00 (utilisation : official, ), <a href="http://terminology.hl7.org/7.0.0/NamingSystem-ClinicalTrialsGov.html" title="The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed [ClinicalTrials.gov](http://clinicaltrials.gov) to provide patients, family members, and members of the public current information about clinical research studies. [ClinicalTrials.gov](http://clinicaltrials.gov) contains summary information about clinical studies being conducted throughout the United States and in many countries throughout the world. These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies.

[ClinicalTrials.gov](http://clinicaltrials.gov) is updated daily. You should check [ClinicalTrials.gov](http://clinicaltrials.gov) frequently for updated information.

More information about ClinicalTrials.gov can be found [here](https://clinicaltrials.gov/about-site/about-ctg).">ClinicalTrials.gov</a>/NCT12345678 (utilisation : secondary, ), <code>https://www.isrctn.com</code>/ISRCTN12345678 (utilisation : secondary, ), <code>https://www.who.int/tools/clinical-trials-registry-platform</code>/U1234-3452-7658 (utilisation : secondary, ), <code>https://my-identifier.fr</code>/my-identifier-1234 (utilisation : secondary, )</p><p><b>title</b>: UNE ETUDE DE PHASE III, RANDOMISEE, OUVERTE, EVALUANT L'EFFICACITE ET LA SECURITE DU GIREDESTRANT EN ASSOCIATION AVEC PHESGO.</p><p><b>status</b>: Active</p><p><b>phase</b>: <span title="Codes :{http://terminology.hl7.org/CodeSystem/research-study-phase phase-3}">Phase 3</span></p><p><b>category</b>: <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-regulation-code-code-system REG536}">REG536 (CTIS)</span>, <span title="Codes :{https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-reglementation-precision-code-system study-ctis}">un essai clinique (CTIS)</span></p><p><b>condition</b>: <span title="Codes :">Cancer du sein localement avancé ou métastatique (CSM)</span>, <span title="Codes :{https://www.meddra.org 12345678}">Cancer du sein HER2 positif</span>, <span title="Codes :{https://www.meddra.org 87654321}">Cancer du sein à récepteurs aux oestrogènes positifs</span></p><p><b>contact</b>: ph: 0041616881111(Work),<a href="mailto:global.rochegenentechtrials@roche.com">global.rochegenentechtrials@roche.com</a>, ph: -unknown-(Work),<a href="mailto:null"/>, ph: -unknown-(Work),<a href="mailto:null"/></p><p><b>location</b>: <span title="Codes :{urn:iso:std:iso:3166 BE}">Belgium</span>, <span title="Codes :{urn:iso:std:iso:3166 DE}">Germany</span>, <span title="Codes :{urn:iso:std:iso:3166 ES}">Spain</span>, <span title="Codes :{urn:iso:std:iso:3166 FR}">France</span>, <span title="Codes :{urn:iso:std:iso:3166 HU}">Hungary</span>, <span title="Codes :{urn:iso:std:iso:3166 IT}">Italy</span>, <span title="Codes :{urn:iso:std:iso:3166 PL}">Poland</span>, <span title="Codes :{urn:iso:std:iso:3166 PT}">Portugal</span></p><p><b>description</b>: </p><div><p>Exemple construit à partir de https://eclaire-api.osc-fr1.scalingo.io/R4/ResearchStudy/2022-500014-26-00</p>
</div><p><b>enrollment</b>: <a href="Group/2022-500014-26-00-enrollment-group">Reference to group detailing study characteristics</a></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>Example</td><td>Example</td></tr></table></div>
  </text>
  <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/2022-500014-26-00-secondary-sponsor"/>
        <display value="Reference to secondary sponsor"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area">
    <valueString value="Maladies [C] - Tumeurs [C04]"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
    <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="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>
  <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-review-date">
    <valueInstant value="2024-05-31T00:00:00.000Z"/>
  </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>
  <identifier>
    <use value="official"/>
    <system value="https://euclinicaltrials.eu"/>
    <value value="2022-500014-26-00"/>
  </identifier>
  <identifier>
    <use value="secondary"/>
    <system value="http://clinicaltrials.gov"/>
    <value value="NCT12345678"/>
  </identifier>
  <identifier>
    <use value="secondary"/>
    <system value="https://www.isrctn.com"/>
    <value value="ISRCTN12345678"/>
  </identifier>
  <identifier>
    <use value="secondary"/>
    <system
            value="https://www.who.int/tools/clinical-trials-registry-platform"/>
    <value value="U1234-3452-7658"/>
  </identifier>
  <identifier>
    <use value="secondary"/>
    <system value="https://my-identifier.fr"/>
    <value value="my-identifier-1234"/>
  </identifier>
  <title
         value="UNE ETUDE DE PHASE III, RANDOMISEE, OUVERTE, EVALUANT L'EFFICACITE ET LA SECURITE DU GIREDESTRANT EN ASSOCIATION AVEC PHESGO."/>
  <status value="active"/>
  <phase>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <code value="phase-3"/>
      <display value="Phase 3"/>
    </coding>
  </phase>
  <category>
    <coding>
      <system
              value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-regulation-code-code-system"/>
      <code value="REG536"/>
      <display value="REG536 (CTIS)"/>
    </coding>
  </category>
  <category>
    <coding>
      <system
              value="https://interop.esante.gouv.fr/ig/fhir/eclaire/CodeSystem/eclaire-reglementation-precision-code-system"/>
      <code value="study-ctis"/>
      <display value="un essai clinique (CTIS)"/>
    </coding>
  </category>
  <condition id="disease-condition-2022-500014-26-00">
    <text value="Cancer du sein localement avancé ou métastatique (CSM)"/>
  </condition>
  <condition id="meddra-condition-2022-500014-26-00-10065430">
    <coding>
      <system value="https://www.meddra.org"/>
      <code value="12345678"/>
      <display value="Cancer du sein HER2 positif"/>
    </coding>
  </condition>
  <condition id="meddra-condition-2022-500014-26-00-10070575">
    <coding>
      <system value="https://www.meddra.org"/>
      <code value="87654321"/>
      <display value="Cancer du sein à récepteurs aux oestrogènes positifs"/>
    </coding>
  </condition>
  <contact>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name">
      <valueHumanName>
        <use value="official"/>
        <family value="Trial Information Support Line-TISL, Switzerland"/>
        <given value="Head of EU"/>
      </valueHumanName>
    </extension>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address">
      <valueAddress>
        <use value="work"/>
        <type value="physical"/>
      </valueAddress>
    </extension>
    <telecom>
      <system value="phone"/>
      <value value="0041616881111"/>
      <use value="work"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="global.rochegenentechtrials@roche.com"/>
      <use value="work"/>
    </telecom>
  </contact>
  <contact>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name">
      <valueHumanName>
        <use value="official"/>
      </valueHumanName>
    </extension>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address">
      <valueAddress>
        <use value="work"/>
        <type value="physical"/>
      </valueAddress>
    </extension>
    <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="SCI"/>
          <display value="Scientifique / Scientific"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <telecom>
      <system value="phone"/>
      <use value="work"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <use value="work"/>
    </telecom>
  </contact>
  <contact>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name">
      <valueHumanName>
        <use value="official"/>
      </valueHumanName>
    </extension>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address">
      <valueAddress>
        <use value="work"/>
        <type value="physical"/>
      </valueAddress>
    </extension>
    <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"/>
          <display value="Publique / Public"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <telecom>
      <system value="phone"/>
      <use value="work"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <use value="work"/>
    </telecom>
  </contact>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="BE"/>
      <display value="Belgium"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="DE"/>
      <display value="Germany"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="ES"/>
      <display value="Spain"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="FR"/>
      <display value="France"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="HU"/>
      <display value="Hungary"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="IT"/>
      <display value="Italy"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="PL"/>
      <display value="Poland"/>
    </coding>
  </location>
  <location>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="PT"/>
      <display value="Portugal"/>
    </coding>
  </location>
  <description
               value="Exemple construit à partir de https://eclaire-api.osc-fr1.scalingo.io/R4/ResearchStudy/2022-500014-26-00"/>
  <enrollment>
    <reference value="Group/2022-500014-26-00-enrollment-group"/>
    <type value="Group"/>
    <display value="Reference to group detailing study characteristics"/>
  </enrollment>
  <arm>
    <extension
               url="https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention">
      <extension url="name">
        <valueString value="Nom de l'intervention example"/>
      </extension>
      <extension url="description">
        <valueString value="Description de l'intervention example"/>
      </extension>
    </extension>
    <name value="Example"/>
    <description value="Example"/>
  </arm>
</ResearchStudy>