<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="mii-pr-studie-proband" />
  <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-proband" />
  <version value="2027.0.0-ballot" />
  <name value="MII_PR_Studie_Proband" />
  <title value="MII PR Studie Proband">
    <extension url="http://hl7.org/fhir/StructureDefinition/translation">
      <extension url="lang">
        <valueCode value="de" />
      </extension>
      <extension url="content">
        <valueString value="MII PR Studie Proband" />
      </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 Subject" />
      </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 Proband*in 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 Proband*in 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 subject within the Medical Informatics Initiative." />
      </extension>
    </extension>
  </description>
  <fhirVersion value="4.0.1" />
  <kind value="resource" />
  <abstract value="false" />
  <type value="ResearchSubject" />
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchSubject" />
  <derivation value="constraint" />
  <differential>
    <element id="ResearchSubject.id">
      <path value="ResearchSubject.id" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.meta">
      <path value="ResearchSubject.meta" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.meta.profile">
      <path value="ResearchSubject.meta.profile" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier">
      <path value="ResearchSubject.identifier" />
      <slicing>
        <discriminator>
          <type value="pattern" />
          <path value="$this" />
        </discriminator>
        <rules value="open" />
      </slicing>
      <short value="Identifier des Probanden">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Identifier des Probanden." />
          </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 subject." />
          </extension>
        </extension>
      </short>
      <definition value="Kennungen, die dem Probanden zugewiesen wurden.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Kennungen, die dem Probanden 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 study subject by the sponsor or other systems." />
          </extension>
        </extension>
      </definition>
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier:subjectIdentificationCode">
      <path value="ResearchSubject.identifier" />
      <sliceName value="subjectIdentificationCode" />
      <min value="1" />
      <max value="1" />
      <patternIdentifier>
        <type>
          <coding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0203" />
            <code value="ANON" />
          </coding>
        </type>
      </patternIdentifier>
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier:subjectIdentificationCode.type">
      <path value="ResearchSubject.identifier.type" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier:subjectIdentificationCode.system">
      <path value="ResearchSubject.identifier.system" />
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier:subjectIdentificationCode.value">
      <path value="ResearchSubject.identifier.value" />
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.status">
      <path value="ResearchSubject.status" />
      <short value="Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn" />
          </extension>
        </extension>
      </short>
      <definition value="Status der Teilnahme">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Status der Teilnahme." />
          </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 participation." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.period">
      <path value="ResearchSubject.period" />
      <short value="Anfang und Ende der Teilnahme">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Anfang und Ende der Teilnahme" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Start and end of participation." />
          </extension>
        </extension>
      </short>
      <definition value="Zeitrum, in denen die Teilnahme an der Studie begann und endete.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Zeitraum, in dem die Teilnahme an der Studie begann und endete." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="The dates the subject began and ended their participation in the study." />
          </extension>
        </extension>
      </definition>
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.period.start">
      <path value="ResearchSubject.period.start" />
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.period.end">
      <path value="ResearchSubject.period.end" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.study">
      <path value="ResearchSubject.study" />
      <short value="Studie, der der Proband angehört">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Studie, der der Proband angehört" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="study subject is part of" />
          </extension>
        </extension>
      </short>
      <definition value="Referenz auf die Studie, an der der Proband teilnimmt">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Referenz auf die Studie, an der der Proband teilnimmt." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Reference to the study the subject is participating in." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.individual">
      <path value="ResearchSubject.individual" />
      <short value="Wer an der Studie teilnimmt.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Wer an der Studie teilnimmt." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Who is part of study." />
          </extension>
        </extension>
      </short>
      <definition value="Der Datensatz der Person oder des Tieres, das an der Studie beteiligt ist.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Der Datensatz der Person oder des Tieres, das an der Studie beteiligt ist." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="The record of the person or animal who is involved in the study." />
          </extension>
        </extension>
      </definition>
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.consent">
      <path value="ResearchSubject.consent" />
      <short value="Einverständnis zur Studienteilnahme">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Einverständnis zur Studienteilnahme" />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="Agreement to participate in study" />
          </extension>
        </extension>
      </short>
      <definition value="Ein Datensatz der informierten Zustimmung des Patienten zur Teilnahme an der Studie.">
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="de" />
          </extension>
          <extension url="content">
            <valueString value="Ein Datensatz der informierten Zustimmung des Patienten zur Teilnahme an der Studie." />
          </extension>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/translation">
          <extension url="lang">
            <valueCode value="en" />
          </extension>
          <extension url="content">
            <valueString value="A record of the patient's informed agreement to participate in the study." />
          </extension>
        </extension>
      </definition>
      <min value="1" />
      <mustSupport value="true" />
    </element>
  </differential>
</StructureDefinition>