{
  "resourceType": "StructureDefinition",
  "id": "mii-pr-studie-proband",
  "url": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband",
  "version": "2026.0.1",
  "name": "MII_PR_Studie_Proband",
  "title": "MII PR Studie Proband",
  "_title": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/StructureDefinition/translation",
        "extension": [
          {
            "url": "lang",
            "valueCode": "de"
          },
          {
            "url": "content",
            "valueString": "MII PR Studie Proband"
          }
        ]
      },
      {
        "url": "http://hl7.org/fhir/StructureDefinition/translation",
        "extension": [
          {
            "url": "lang",
            "valueCode": "en"
          },
          {
            "url": "content",
            "valueString": "MII PR Study Subject"
          }
        ]
      }
    ]
  },
  "status": "active",
  "publisher": "Medizininformatik Initiative",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "https://www.medizininformatik-initiative.de"
        }
      ]
    }
  ],
  "description": "Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative.",
  "_description": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/StructureDefinition/translation",
        "extension": [
          {
            "url": "lang",
            "valueCode": "de"
          },
          {
            "url": "content",
            "valueString": "Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative."
          }
        ]
      },
      {
        "url": "http://hl7.org/fhir/StructureDefinition/translation",
        "extension": [
          {
            "url": "lang",
            "valueCode": "en"
          },
          {
            "url": "content",
            "valueString": "This profile describes a study subject within the Medical Informatics Initiative."
          }
        ]
      }
    ]
  },
  "fhirVersion": "4.0.1",
  "kind": "resource",
  "abstract": false,
  "type": "ResearchSubject",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "ResearchSubject.id",
        "path": "ResearchSubject.id",
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.meta",
        "path": "ResearchSubject.meta",
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.meta.profile",
        "path": "ResearchSubject.meta.profile",
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.identifier",
        "path": "ResearchSubject.identifier",
        "slicing": {
          "discriminator": [
            {
              "type": "pattern",
              "path": "$this"
            }
          ],
          "rules": "open"
        },
        "short": "Identifier des Probanden",
        "_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."
                }
              ]
            }
          ]
        },
        "definition": "Kennungen, die dem Probanden zugewiesen wurden.",
        "_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."
                }
              ]
            }
          ]
        },
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.identifier:subjectIdentificationCode",
        "path": "ResearchSubject.identifier",
        "sliceName": "subjectIdentificationCode",
        "min": 1,
        "max": "1",
        "patternIdentifier": {
          "type": {
            "coding": [
              {
                "code": "ANON",
                "system": "http://terminology.hl7.org/CodeSystem/v2-0203"
              }
            ]
          }
        },
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.identifier:subjectIdentificationCode.type",
        "path": "ResearchSubject.identifier.type",
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.identifier:subjectIdentificationCode.system",
        "path": "ResearchSubject.identifier.system",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.identifier:subjectIdentificationCode.value",
        "path": "ResearchSubject.identifier.value",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.status",
        "path": "ResearchSubject.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": "Status der Teilnahme",
        "_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
      },
      {
        "id": "ResearchSubject.period",
        "path": "ResearchSubject.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": "Zeitrum, in denen die Teilnahme an der Studie begann und endete.",
        "_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."
                }
              ]
            }
          ]
        },
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.period.start",
        "path": "ResearchSubject.period.start",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.period.end",
        "path": "ResearchSubject.period.end",
        "mustSupport": true
      },
      {
        "id": "ResearchSubject.study",
        "path": "ResearchSubject.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": "Referenz auf die Studie, an der der Proband teilnimmt",
        "_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
      },
      {
        "id": "ResearchSubject.individual",
        "path": "ResearchSubject.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": "Der Datensatz der Person oder des Tieres, das an der Studie beteiligt ist.",
        "_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
      },
      {
        "id": "ResearchSubject.consent",
        "path": "ResearchSubject.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": "Ein Datensatz der informierten Zustimmung des Patienten zur Teilnahme an der Studie.",
        "_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."
                }
              ]
            }
          ]
        },
        "min": 1,
        "mustSupport": true
      }
    ]
  }
}