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

: Research Study Category Code System

Active Stand: 2026-01-09

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{
  "resourceType" : "CodeSystem",
  "id" : "research-study-category-cs",
  "meta" : {
    "extension" : [
      {
        "url" : "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-license",
        "valueCode" : "CC-BY-4.0"
      },
      {
        "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"
          }
        ],
        "url" : "http://hl7.org/fhir/StructureDefinition/package-source"
      }
    ],
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablecodesystem"🔗 ,
      "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablecodesystem"
    ]
  },
  "language" : "de",
  "text" : {
    "status" : "generated",
    "div" : "<div xml:lang=\"de\" lang=\"de\"><hr/><p><b>German</b></p><hr/><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem research-study-category-cs</b></p><a name=\"research-study-category-cs\"> </a><a name=\"hcresearch-study-category-cs\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profiles: <a href=\"http://hl7.org/fhir/uv/crmi/STU2/StructureDefinition-crmi-shareablecodesystem.html\">CRMI Shareable CodeSystem</a>, <a href=\"http://hl7.org/fhir/uv/crmi/STU2/StructureDefinition-crmi-publishablecodesystem.html\">CRMI Publishable CodeSystem</a></p></div><p>This case-sensitive code system <code>http://example.org/fhir/CodeSystem/research-study-category</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">interventional<a name=\"research-study-category-cs-interventional\"> </a></td><td>Interventional study</td><td>A study in which participants are assigned to receive one or more interventions so that outcomes can be evaluated.</td></tr><tr><td style=\"white-space:nowrap\">observational<a name=\"research-study-category-cs-observational\"> </a></td><td>Observational study</td><td>A study in which biomedical or health outcomes are observed in a defined population without assignment of specific interventions.</td></tr><tr><td style=\"white-space:nowrap\">registry<a name=\"research-study-category-cs-registry\"> </a></td><td>Registry study</td><td>A study primarily based on data collected in a registry (e.g. disease or quality registry).</td></tr><tr><td style=\"white-space:nowrap\">other<a name=\"research-study-category-cs-other\"> </a></td><td>Other</td><td>Other study category not covered by the existing codes. Use with additional descriptive text.</td></tr></table></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm",
      "valueCoding" : {
        "system" : "http://hl7.org/fhir/version-algorithm",
        "code" : "semver",
        "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" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes",
            "version" : "3.0.0",
            "code" : "package",
            "display" : "Package"
          }
        ]
      }
    },
    {
      "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" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C15206"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/artifact-topic",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C15429"
          }
        ]
      }
    },
    {
      "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" : "http://example.org/fhir/CodeSystem/research-study-category",
  "version" : "2027.0.0-ballot",
  "name" : "ResearchStudyCategoryCS",
  "title" : "Research Study Category Code System",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-01-09",
  "publisher" : "NUM-DIZ",
  "contact" : [
    {
      "name" : "NUM-DIZ",
      "telecom" : [
        {
          "system" : "url",
          "value" : "https://www.netzwerk-universitaetsmedizin.de"
        }
      ]
    }
  ],
  "description" : "High-level categories describing the overall type of a research study.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "DE",
          "display" : "Germany"
        }
      ]
    }
  ],
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 4,
  "concept" : [
    {
      "code" : "interventional",
      "display" : "Interventional study",
      "definition" : "A study in which participants are assigned to receive one or more interventions so that outcomes can be evaluated."
    },
    {
      "code" : "observational",
      "display" : "Observational study",
      "definition" : "A study in which biomedical or health outcomes are observed in a defined population without assignment of specific interventions."
    },
    {
      "code" : "registry",
      "display" : "Registry study",
      "definition" : "A study primarily based on data collected in a registry (e.g. disease or quality registry)."
    },
    {
      "code" : "other",
      "display" : "Other",
      "definition" : "Other study category not covered by the existing codes. Use with additional descriptive text."
    }
  ]
}