<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="mii-pr-studie-proband" />
  <url value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband" />
  <version value="2026.0.1" />
  <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" />
  <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>