{
  "resourceType": "StructureDefinition",
  "id": "mii-pr-studie-proband",
  "meta": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-license",
        "valueCode": "CC-BY-4.0"
      },
      {
        "url": "http://hl7.org/fhir/StructureDefinition/package-source",
        "extension": [
          {
            "url": "packageId",
            "valueId": "de.medizininformatikinitiative.kerndatensatz.studie"
          },
          {
            "url": "version",
            "valueString": "2027.0.0-ballot"
          },
          {
            "url": "uri",
            "valueUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie"
          }
        ]
      }
    ],
    "profile": [
      "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablestructuredefinition",
      "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablestructuredefinition"
    ]
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm",
      "valueCoding": {
        "code": "semver",
        "system": "http://hl7.org/fhir/version-algorithm",
        "display": "SemVer"
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability",
      "valueCode": "shareable"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability",
      "valueCode": "publishable"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy",
      "valueCodeableConcept": {
        "coding": [
          {
            "code": "package",
            "system": "http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes",
            "version": "3.0.0",
            "display": "Package"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-usage",
      "valueMarkdown": "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."
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/resource-approvalDate",
      "valueDate": "2026-01-09"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod",
      "valuePeriod": {
        "start": "2027"
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-topic",
      "valueCodeableConcept": {
        "coding": [
          {
            "code": "C15206",
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-topic",
      "valueCodeableConcept": {
        "coding": [
          {
            "code": "C15429",
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-author",
      "valueContactDetail": {
        "name": "Matthias Löbe",
        "telecom": [
          {
            "system": "email",
            "value": "matthias.loebe@imise.uni-leipzig.de"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
      "valueContactDetail": {
        "name": "Taskforce Core Data Set"
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
      "valueContactDetail": {
        "name": "Thomas Debertshäuser",
        "telecom": [
          {
            "system": "email",
            "value": "thomas.debertshaeuser@charite.de"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
      "valueContactDetail": {
        "name": "Margaux Gatrio",
        "telecom": [
          {
            "system": "email",
            "value": "margaux.gatrio@bih-charite.de"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer",
      "valueContactDetail": {
        "name": "Interoperability Working Group",
        "telecom": [
          {
            "system": "url",
            "value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer",
      "valueContactDetail": {
        "name": "National Steering Committee",
        "telecom": [
          {
            "system": "url",
            "value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser",
      "valueContactDetail": {
        "name": "Interoperability Working Group",
        "telecom": [
          {
            "system": "url",
            "value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser",
      "valueContactDetail": {
        "name": "National Steering Committee",
        "telecom": [
          {
            "system": "url",
            "value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"
          }
        ]
      }
    }
  ],
  "url": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband",
  "version": "2027.0.0-ballot",
  "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",
  "experimental": false,
  "date": "2026-01-09",
  "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
      }
    ]
  }
}