<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="mii-pr-studie-studie" />
  <meta>
    <extension url="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-license">
      <valueCode value="CC-BY-4.0" />
    </extension>
    <extension url="http://hl7.org/fhir/StructureDefinition/package-source">
      <extension url="packageId">
        <valueId value="de.medizininformatikinitiative.kerndatensatz.studie" />
      </extension>
      <extension url="version">
        <valueString value="2027.0.0-ballot" />
      </extension>
      <extension url="uri">
        <valueUri value="https://www.medizininformatik-initiative.de/fhir/modul-studie" />
      </extension>
    </extension>
    <profile value="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablestructuredefinition" />
    <profile value="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablestructuredefinition" />
  </meta>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm">
    <valueCoding>
      <system value="http://hl7.org/fhir/version-algorithm" />
      <code value="semver" />
      <display value="SemVer" />
    </valueCoding>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability">
    <valueCode value="shareable" />
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability">
    <valueCode value="publishable" />
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy">
    <valueCodeableConcept>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes" />
        <version value="3.0.0" />
        <code value="package" />
        <display value="Package" />
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-usage">
    <valueMarkdown value="Use this profile as the technical FHIR representation of the corresponding Medical Informatics Initiative logical model. The profile constrains a base FHIR resource for the MII module context by specifying how elements are used, which elements are required or not used, which extensions and terminology bindings apply, and how the resource maps to the module-specific content model. Implementers should produce and consume resource instances that conform to this profile when exchanging data for the corresponding MII module." />
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/resource-approvalDate">
    <valueDate value="2026-01-09" />
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod">
    <valuePeriod>
      <start value="2027" />
    </valuePeriod>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-topic">
    <valueCodeableConcept>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl" />
        <code value="C15206" />
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-topic">
    <valueCodeableConcept>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl" />
        <code value="C15429" />
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
    <valueContactDetail>
      <name value="Matthias Löbe" />
      <telecom>
        <system value="email" />
        <value value="matthias.loebe@imise.uni-leipzig.de" />
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
    <valueContactDetail>
      <name value="Taskforce Core Data Set" />
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
    <valueContactDetail>
      <name value="Thomas Debertshäuser" />
      <telecom>
        <system value="email" />
        <value value="thomas.debertshaeuser@charite.de" />
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
    <valueContactDetail>
      <name value="Margaux Gatrio" />
      <telecom>
        <system value="email" />
        <value value="margaux.gatrio@bih-charite.de" />
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-reviewer">
    <valueContactDetail>
      <name value="Interoperability Working Group" />
      <telecom>
        <system value="url" />
        <value value="https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group" />
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-reviewer">
    <valueContactDetail>
      <name value="National Steering Committee" />
      <telecom>
        <system value="url" />
        <value value="https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee" />
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-endorser">
    <valueContactDetail>
      <name value="Interoperability Working Group" />
      <telecom>
        <system value="url" />
        <value value="https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group" />
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-endorser">
    <valueContactDetail>
      <name value="National Steering Committee" />
      <telecom>
        <system value="url" />
        <value value="https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee" />
      </telecom>
    </valueContactDetail>
  </extension>
  <url value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie" />
  <version value="2027.0.0-ballot" />
  <name value="MII_PR_Studie_Studie" />
  <title value="MII PR Studie Studie">
    <extension url="http://hl7.org/fhir/StructureDefinition/translation">
      <extension url="lang">
        <valueCode value="de" />
      </extension>
      <extension url="content">
        <valueString value="MII PR Studie Studie" />
      </extension>
    </extension>
    <extension url="http://hl7.org/fhir/StructureDefinition/translation">
      <extension url="lang">
        <valueCode value="en" />
      </extension>
      <extension url="content">
        <valueString value="MII PR Study Study" />
      </extension>
    </extension>
  </title>
  <status value="active" />
  <experimental value="false" />
  <date value="2026-01-09" />
  <publisher value="Medizininformatik Initiative" />
  <contact>
    <telecom>
      <system value="url" />
      <value value="https://www.medizininformatik-initiative.de" />
    </telecom>
  </contact>
  <description value="Dieses Profil beschreibt eine Studie in der Medizininformatik-Initiative.">
    <extension url="http://hl7.org/fhir/StructureDefinition/translation">
      <extension url="lang">
        <valueCode value="de" />
      </extension>
      <extension url="content">
        <valueString value="Dieses Profil beschreibt eine Studie in der Medizininformatik-Initiative." />
      </extension>
    </extension>
    <extension url="http://hl7.org/fhir/StructureDefinition/translation">
      <extension url="lang">
        <valueCode value="en" />
      </extension>
      <extension url="content">
        <valueString value="This profile describes a study within the Medical Informatics Initiative." />
      </extension>
    </extension>
  </description>
  <fhirVersion value="4.0.1" />
  <kind value="resource" />
  <abstract value="false" />
  <type value="ResearchStudy" />
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" />
  <derivation value="constraint" />
  <differential>
    <element id="ResearchStudy.extension">
      <path value="ResearchStudy.extension" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Label">
      <path value="ResearchStudy.extension" />
      <sliceName value="Label" />
      <short value="Label">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Backport Label" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Backport Label" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="*" />
      <type>
        <code value="Extension" />
        <profile value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:AssociatedParty">
      <path value="ResearchStudy.extension" />
      <sliceName value="AssociatedParty" />
      <short value="AssociatedParty">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Backport AssociatedParty" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Backport AssociatedParty" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="*" />
      <type>
        <code value="Extension" />
        <profile value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Ethikvotum">
      <path value="ResearchStudy.extension" />
      <sliceName value="Ethikvotum" />
      <short value="Ethikvotum">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Ethikvotum" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Ethikvotum" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="*" />
      <type>
        <code value="Extension" />
        <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Studienregister">
      <path value="ResearchStudy.extension" />
      <sliceName value="Studienregister" />
      <short value="Studienregister">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Studienregister" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Studienregister" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="*" />
      <type>
        <code value="Extension" />
        <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Eligibility">
      <path value="ResearchStudy.extension" />
      <sliceName value="Eligibility" />
      <short value="Eligibility">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Eligibility" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Eligibility" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="1" />
      <type>
        <code value="Extension" />
        <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Akronym">
      <path value="ResearchStudy.extension" />
      <sliceName value="Akronym" />
      <short value="Akronym">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Akronym" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Akronym" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="1" />
      <type>
        <code value="Extension" />
        <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Rekrutierung">
      <path value="ResearchStudy.extension" />
      <sliceName value="Rekrutierung" />
      <short value="Rekrutierung">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Rekrutierung" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Rekrutierung" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="1" />
      <type>
        <code value="Extension" />
        <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.extension:Finanzierung">
      <path value="ResearchStudy.extension" />
      <sliceName value="Finanzierung" />
      <short value="Finanzierung">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Finanzierung" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="MII EX Studie Finanzierung" />
          </extension>
        </extension>
      </short>
      <definition value="Optionales Erweiterungselement – in allen Ressourcen vorhanden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Optionales Erweiterungselement – in allen Ressourcen vorhanden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Optional Extension Element - found in all resources." />
          </extension>
        </extension>
      </definition>
      <min value="0" />
      <max value="*" />
      <type>
        <code value="Extension" />
        <profile value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.identifier">
      <path value="ResearchStudy.identifier" />
      <short value="Name für diese Studie">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Name für diese Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Business Identifier for study." />
          </extension>
        </extension>
      </short>
      <definition value="Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Identifiers assigned to this research study by the sponsor or other systems." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.identifier.system">
      <path value="ResearchStudy.identifier.system" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.identifier.value">
      <path value="ResearchStudy.identifier.value" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.title">
      <path value="ResearchStudy.title" />
      <short value="Name für diese Studie">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Name für diese Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Name for this study." />
          </extension>
        </extension>
      </short>
      <definition value="Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="A short, descriptive user-friendly label for the study." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.partOf">
      <path value="ResearchStudy.partOf" />
      <short value="Teil einer größeren Studie.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Teil einer größeren Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Part of larger study." />
          </extension>
        </extension>
      </short>
      <definition value="Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="A larger research study of which this particular study is a component or step." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.status">
      <path value="ResearchStudy.status" />
      <short value="aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn" />
          </extension>
        </extension>
      </short>
      <definition value="Der aktuelle Status der Studie.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Der aktuelle Status der Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="The current state of the study." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.category">
      <path value="ResearchStudy.category" />
      <short value="Klassifikationen für die Studie.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Klassifikationen für die Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Classifications for the study." />
          </extension>
        </extension>
      </short>
      <definition value="Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.focus">
      <path value="ResearchStudy.focus" />
      <short value="Untersuchte Medikamente, Geräte usw.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Untersuchte Medikamente, Geräte usw." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Drugs, devices, etc. under study" />
          </extension>
        </extension>
      </short>
      <definition value="Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="The medication, food, therapy, device or other concerns or interventions that the study is seeking to gain more information about." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.focus.text">
      <path value="ResearchStudy.focus.text" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.keyword">
      <path value="ResearchStudy.keyword" />
      <short value="Wird verwendet, um nach der Studie zu suchen.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Wird verwendet, um nach der Studie zu suchen." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Used to search for the study." />
          </extension>
        </extension>
      </short>
      <definition value="Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Key terms to aid in searching for or filtering the study." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.keyword.text">
      <path value="ResearchStudy.keyword.text" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.arm">
      <path value="ResearchStudy.arm" />
      <short value="Definierter Weg durch die Studie für ein Subjekt.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Definierter Weg durch die Studie für ein Subjekt." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Defined path through the study for a subject." />
          </extension>
        </extension>
      </short>
      <definition value="Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchStudy.arm.name">
      <path value="ResearchStudy.arm.name" />
      <mustSupport value="true" />
    </element>
  </differential>
</StructureDefinition>