MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

: mii-studie-test-data-bundle-studie

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  "language" : "en",
  "type" : "transaction",
  "timestamp" : "2025-12-04T12:00:00+00:00",
  "entry" : [
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        },
        "content" : [
          {
            "attachment" : {
              "contentType" : "application/pdf",
              "url" : "https://example.com/fhir/Binary/document",
              "size" : 2000,
              "title" : "Beispiel Dokument"
            }
          }
        ],
        "context" : {
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            {
              🔗 "reference" : "ResearchStudy/mii-exa-studie-cohort"
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                "valueReference" : {
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              }
            ],
            "description" : "Altersbeschränkung",
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          {
            "extension" : [
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              }
            ],
            "description" : "Geschlecht",
            "definitionCodeableConcept" : {
              "text" : "Alle"
            },
            "exclude" : false
          },
          {
            "extension" : [
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            "description" : "Kognitive Fatigue (WeiMUS kognitive Skala >= 17)",
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            ],
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          },
          {
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              {
                "url" : "rekrutierungsstand-datum",
                "valueDate" : "2023-02-17"
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            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung",
            "valueString" : "Öffentliche Förderinstitutionen, aus Steuermitteln getragene Institutionen (DFG, BMBF u. a.)"
          },
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                "valueString" : "Zustimmende Bewertung"
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                "url" : "ethiknummer",
                "valueString" : "Az.: 83/18"
              }
            ],
            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum"
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        ],
        "identifier" : [
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            "system" : "https://example.com/fhir/sid/drks",
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        ],
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        "category" : [
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            ]
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        "resourceType" : "ResearchStudy",
        "id" : "mii-exa-studie-cohort",
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        "language" : "en",
        "text" : {
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        },
        "extension" : [
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                "valueString" : "MII Modul Studie"
              }
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            "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label"
          },
          {
            "extension" : [
              {
                "url" : "role",
                "valueCodeableConcept" : {
                  "coding" : [
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                      "code" : "sponsor"
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                  ]
                }
              },
              {
                "url" : "party",
                "valueReference" : {
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              }
            ],
            "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty"
          },
          {
            "extension" : [
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                "url" : "status",
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                "url" : "kommission",
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              {
                "url" : "ethiknummer",
                "valueString" : "159-12-21052012"
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          },
          {
            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister",
            "valueReference" : {
              🔗 "reference" : "Library/mii-exa-studie-register"
            }
          },
          {
            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility",
            "valueReference" : {
              🔗 "reference" : "EvidenceVariable/mii-exa-studie-ein-auschluss-kriterium"
            }
          },
          {
            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym",
            "valueString" : "LIFE ADULT"
          },
          {
            "extension" : [
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                "url" : "rekrutierungsstart",
                "valueDate" : "2009-01-01"
              },
              {
                "url" : "rekrutierungsziel",
                "valueInteger" : 10000
              },
              {
                "url" : "rekrutierungsstand",
                "valueInteger" : 10000
              },
              {
                "url" : "rekrutierungsstand-genauigkeit",
                "valueString" : "good"
              },
              {
                "url" : "rekrutierungsstand-datum",
                "valueDate" : "2022-05-28"
              }
            ],
            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung"
          },
          {
            "url" : "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung",
            "valueString" : "Deutsches Bundesministerium für Bildung und Forschung (BMBF)"
          }
        ],
        "identifier" : [
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            "system" : "https://example.com/fhir/sid/lha",
            "value" : "7Q6PJD8NV3-2"
          }
        ],
        "title" : "LIFE-Adult-Study",
        "partOf" : [
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            🔗 "reference" : "ResearchStudy/mii-exa-studie-reference-study"
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        ],
        "status" : "active",
        "category" : [
          {
            "coding" : [
              {
                "system" : "http://example.org/fhir/CodeSystem/research-study-category",
                "code" : "observational"
              }
            ]
          }
        ],
        "focus" : [
          {
            "text" : "Erwachsene der Stadt Leipzig"
          }
        ],
        "keyword" : [
          {
            "text" : "Bevölkerung, Leipzig, Erwachsene"
          }
        ],
        "description" : "Die LIFE Adult-Studie ist eine langfristig angelegte, bevölkerungsbezogene Kohortenstudie. Stichproben aus der Leipziger Erwachsenenbevölkerung werden hinsichtlich vielfältiger Merkmale und Krankheitsrisiken umfassend untersucht. Insbesondere die Häufigkeit von Volkskrankheiten steht im Mittelpunkt der Forschungsarbeiten. Der Einfluss von Lebensstil- und Umweltfaktoren auf diese Erkrankungen wird charak​terisiert. Bisher unbekannte Risikofaktoren für die Entstehung von Volkskrankheiten sollen aufgespürt und neue Möglichkeiten der Früherkennung entwickelt werden.",
        "arm" : [
          {
            "name" : "LIFE-Adult-Kohorte"
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "MII_PR_Studie_Cohort"
      }
    },
    {
      "fullUrl" : "https://www.medizininformatik-initiative.de/MII_PR_Studie_Proband/mii-exa-studie-proband",
      "resource" : {
        "resourceType" : "ResearchSubject",
        "id" : "mii-exa-studie-proband",
        "meta" : {
          "profile" : [
            🔗 "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband"
          ],
          "security" : [
            {
              "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
              "code" : "HTEST",
              "display" : "test health data"
            }
          ]
        },
        "language" : "en",
        "text" : {
          "status" : "generated"
        },
        "identifier" : [
          {
            "type" : {
              "coding" : [
                {
                  "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                  "code" : "ANON"
                }
              ]
            },
            "system" : "https://www.medizininformatik-initiative.de/fhir/sid/patienten",
            "value" : "321123456"
          }
        ],
        "status" : "candidate",
        "period" : {
          "start" : "2023-01-01",
          "end" : "2023-12-31"
        },
        "study" : {
          🔗 "reference" : "ResearchStudy/mii-exa-studie-cohort"
        },
        "individual" : {
          🔗 "reference" : "Patient/mii-exa-studie-patient"
        },
        "consent" : {
          🔗 "reference" : "Consent/mii-exa-studie-consent"
        }
      },
      "request" : {
        "method" : "POST",
        "url" : "MII_PR_Studie_Proband"
      }
    },
    {
      "fullUrl" : "https://www.medizininformatik-initiative.de/MII_PR_Studie_Beteiligte_Person/mii-exa-studie-beteiligte-person",
      "resource" : {
        "resourceType" : "PractitionerRole",
        "id" : "mii-exa-studie-beteiligte-person",
        "meta" : {
          "profile" : [
            🔗 "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-beteiligte-person"
          ],
          "security" : [
            {
              "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
              "code" : "HTEST",
              "display" : "test health data"
            }
          ]
        },
        "language" : "en",
        "text" : {
          "status" : "generated"
        },
        "practitioner" : {
          🔗 "reference" : "Practitioner/mii-exa-studie-practitioner"
        },
        "organization" : {
          🔗 "reference" : "Organization/mii-exa-studie-practitioner-organization"
        },
        "code" : [
          {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/practitioner-role",
                "code" : "doctor"
              }
            ]
          }
        ],
        "telecom" : [
          {
            "system" : "phone",
            "value" : "0123456789"
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "MII_PR_Studie_Beteiligte_Person"
      }
    },
    {
      "fullUrl" : "https://www.medizininformatik-initiative.de/MII_PR_Studie_Register/mii-exa-studie-register",
      "resource" : {
        "resourceType" : "Library",
        "id" : "mii-exa-studie-register",
        "meta" : {
          "profile" : [
            🔗 "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-register"
          ],
          "security" : [
            {
              "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
              "code" : "HTEST",
              "display" : "test health data"
            }
          ]
        },
        "language" : "en",
        "text" : {
          "status" : "extensions",
          "div" : "<div xml:lang=\"de\" lang=\"de\"><hr/><p><b>German</b></p><hr/><p><b style=\"color: maroon\">Exception parsing generated Narrative (see /tmp/liquid-5a2d0579-448d-44ee-8a2c-6f4b5b9ff49b.html): unexpected non-end of element null::a  at line 105 column 50</b></p></div>"
        },
        "identifier" : [
          {
            "system" : "https://example.com/fhir/sid/drks",
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