description: Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative.
package_name: de.medizininformatikinitiative.kerndatensatz.studie
derivation: constraint
name: MII_PR_Studie_Proband
type: ResearchSubject
elements:
  id: {mustSupport: true, index: 0}
  meta:
    mustSupport: true
    index: 1
    elements:
      profile: {mustSupport: true, index: 2}
  identifier:
    short: Identifier des Probanden
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: 'Kennungen, die dem Probanden vom Sponsor oder anderen Systemen zugewiesen wurden.'}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Identifiers assigned to this study subject by the sponsor or other systems.}
    mustSupport: true
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Identifier des Probanden.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Business Identifier for study subject.}
    index: 3
    slicing:
      rules: open
      discriminator:
      - {path: $this, type: pattern}
      min: 1
      slices:
        subjectIdentificationCode:
          match:
            type:
              coding:
              - {code: ANON, system: 'http://terminology.hl7.org/CodeSystem/v2-0203'}
          schema:
            mustSupport: true
            pattern:
              type: Identifier
              value:
                type:
                  coding:
                  - {code: ANON, system: 'http://terminology.hl7.org/CodeSystem/v2-0203'}
            _required: true
            index: 4
            elements:
              type: {mustSupport: true, index: 5}
              system: {mustSupport: true, index: 6}
              value: {mustSupport: true, index: 7}
            required: [value, system]
  status:
    short: Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Status der Teilnahme.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: The current state of the study participation.}
    mustSupport: true
    index: 8
  period:
    short: Anfang und Ende der Teilnahme
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Anfang und Ende der Teilnahme}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Start and end of participation.}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: 'Zeitraum, in dem die Teilnahme an der Studie begann und endete.'}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: The dates the subject began and ended their participation in the study.}
    mustSupport: true
    index: 9
    elements:
      start: {mustSupport: true, index: 10}
      end: {mustSupport: true, index: 11}
    required: [start]
  study:
    short: Studie, der der Proband angehört
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: 'Studie, der der Proband angehört'}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: study subject is part of}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: 'Referenz auf die Studie, an der der Proband teilnimmt.'}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Reference to the study the subject is participating in.}
    mustSupport: true
    index: 12
  individual:
    short: Wer an der Studie teilnimmt.
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Wer an der Studie teilnimmt.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Who is part of study.}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: 'Der Datensatz der Person oder des Tieres, das an der Studie beteiligt ist.'}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: The record of the person or animal who is involved in the study.}
    mustSupport: true
    index: 13
  consent:
    short: Einverständnis zur Studienteilnahme
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Einverständnis zur Studienteilnahme}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: Agreement to participate in study}
    _definition:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de}
        - {url: content, valueString: Ein Datensatz der informierten Zustimmung des Patienten zur Teilnahme an der Studie.}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: A record of the patient's informed agreement to participate in the study.}
    mustSupport: true
    index: 14
package_version: 2026.0.2-rc1
class: profile
kind: resource
url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband
base: http://hl7.org/fhir/StructureDefinition/ResearchSubject
version: 2026.0.1
required: [consent, identifier, period]