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Packagede.medizininformatikinitiative.kerndatensatz.studie
Resource TypeStructureDefinition
IdStructureDefinition-mii-pr-studie-studie.json
FHIR VersionR4
Sourcehttps://simplifier.net/resolve?scope=de.medizininformatikinitiative.kerndatensatz.studie@2026.0.1&canonical=https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie
URLhttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie
Version2026.0.1
Statusactive
NameMII_PR_Studie_Studie
TitleMII PR Studie Studie
Realmde
DescriptionDieses Profil beschreibt eine Studie in der Medizininformatik-Initiative.
TypeResearchStudy
Kindresource

Resources that use this resource

CapabilityStatement
metadataMII CPS Metadata Studie
StructureDefinition
mii-pr-seltene-studieneinschluss-anfrageMII PR SE Studieneinschluss Anfrage
mii-pr-mtb-studieMII PR MTB Studie
mii-pr-mtb-studieneinschluss-anfrageMII PR MTB Studieneinschluss Anfrage
mii-pr-studie-studieneinschluss-anfrageMII PR Studie Studieneinschluss Anfrage

Resources that this resource uses

StructureDefinition
extension-ResearchStudy.associatedPartyCross-version Extension for R5.ResearchStudy.associatedParty for use in FHIR R4B
extension-ResearchStudy.labelCross-version Extension for R5.ResearchStudy.label for use in FHIR R4B
mii-ex-studie-akronymMII EX Studie Akronym
mii-ex-studie-eligibilityMII EX Studie Eligibility
mii-ex-studie-ethikvotumMII EX Studie Ethikvotum
mii-ex-studie-finanzierungMII EX Studie Finanzierung
mii-ex-studie-rekrutierungMII EX Studie Rekrutierung
mii-ex-studie-studienregisterMII EX Studie Studienregister

Narrative

No narrative content found in resource


Source1

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  "resourceType": "StructureDefinition",
  "id": "mii-pr-studie-studie",
  "url": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie",
  "version": "2026.0.1",
  "name": "MII_PR_Studie_Studie",
  "title": "MII PR Studie Studie",
  "_title": {
    "extension": [
      {
        "url": "http://hl7.org/fhir/StructureDefinition/translation",
        "extension": [
          {
            "url": "lang",
            "valueCode": "de"
          },
          {
            "url": "content",
            "valueString": "MII PR Studie Studie"
          }
        ]
      },
      {
        "url": "http://hl7.org/fhir/StructureDefinition/translation",
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          },
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            "valueString": "MII PR Study Study"
          }
        ]
      }
    ]
  },
  "status": "active",
  "publisher": "Medizininformatik Initiative",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "https://www.medizininformatik-initiative.de"
        }
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    }
  ],
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  "_description": {
    "extension": [
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        "sliceName": "Label",
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                  "valueString": "MII EX Studie Backport Label"
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        "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.",
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        "path": "ResearchStudy.extension",
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        "short": "AssociatedParty",
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        "short": "Ethikvotum",
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        "path": "ResearchStudy.extension",
        "sliceName": "Studienregister",
        "short": "Studienregister",
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        "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.",
        "_definition": {
          "extension": [
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        "path": "ResearchStudy.extension",
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                }
              ]
            }
          ]
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        "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.",
        "_definition": {
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                  "url": "content",
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        "id": "ResearchStudy.extension:Akronym",
        "path": "ResearchStudy.extension",
        "sliceName": "Akronym",
        "short": "Akronym",
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            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
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              ]
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                {
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              ]
            }
          ]
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        "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.",
        "_definition": {
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        "id": "ResearchStudy.extension:Rekrutierung",
        "path": "ResearchStudy.extension",
        "sliceName": "Rekrutierung",
        "short": "Rekrutierung",
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              ]
            }
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        "_definition": {
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        "path": "ResearchStudy.extension",
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        "_short": {
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        "definition": "Optionales Erweiterungselement – in allen Ressourcen vorhanden.",
        "_definition": {
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        },
        "min": 0,
        "max": "*",
        "type": [
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            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.identifier",
        "path": "ResearchStudy.identifier",
        "short": "Name für diese Studie",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Name für diese Studie."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Business Identifier for study."
                }
              ]
            }
          ]
        },
        "definition": "Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Kennungen, die dieser Forschungsstudie 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 research study by the sponsor or other systems."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.identifier.system",
        "path": "ResearchStudy.identifier.system",
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.identifier.value",
        "path": "ResearchStudy.identifier.value",
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.title",
        "path": "ResearchStudy.title",
        "short": "Name für diese Studie",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Name für diese Studie."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Name for this study."
                }
              ]
            }
          ]
        },
        "definition": "Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "A short, descriptive user-friendly label for the study."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.partOf",
        "path": "ResearchStudy.partOf",
        "short": "Teil einer größeren Studie.",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Teil einer größeren Studie."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Part of larger study."
                }
              ]
            }
          ]
        },
        "definition": "Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "A larger research study of which this particular study is a component or step."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.status",
        "path": "ResearchStudy.status",
        "short": "aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen"
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn"
                }
              ]
            }
          ]
        },
        "definition": "Der aktuelle Status der Studie.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Der aktuelle Status der Studie."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "The current state of the study."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.category",
        "path": "ResearchStudy.category",
        "short": "Klassifikationen für die Studie.",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Klassifikationen für die Studie."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Classifications for the study."
                }
              ]
            }
          ]
        },
        "definition": "Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.focus",
        "path": "ResearchStudy.focus",
        "short": "Untersuchte Medikamente, Geräte usw.",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Untersuchte Medikamente, Geräte usw."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Drugs, devices, etc. under study"
                }
              ]
            }
          ]
        },
        "definition": "Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "The medication, food, therapy, device or other concerns or interventions that the study is seeking to gain more information about."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.focus.text",
        "path": "ResearchStudy.focus.text",
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.keyword",
        "path": "ResearchStudy.keyword",
        "short": "Wird verwendet, um nach der Studie zu suchen.",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Wird verwendet, um nach der Studie zu suchen."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Used to search for the study."
                }
              ]
            }
          ]
        },
        "definition": "Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Key terms to aid in searching for or filtering the study."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.keyword.text",
        "path": "ResearchStudy.keyword.text",
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.arm",
        "path": "ResearchStudy.arm",
        "short": "Definierter Weg durch die Studie für ein Subjekt.",
        "_short": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Definierter Weg durch die Studie für ein Subjekt."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Defined path through the study for a subject."
                }
              ]
            }
          ]
        },
        "definition": "Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.",
        "_definition": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "de"
                },
                {
                  "url": "content",
                  "valueString": "Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung."
                }
              ]
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/translation",
              "extension": [
                {
                  "url": "lang",
                  "valueCode": "en"
                },
                {
                  "url": "content",
                  "valueString": "Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."
                }
              ]
            }
          ]
        },
        "mustSupport": true
      },
      {
        "id": "ResearchStudy.arm.name",
        "path": "ResearchStudy.arm.name",
        "mustSupport": true
      }
    ]
  }
}