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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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-category-cs"/>
  <meta>
    <extension
               url="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-license">
      <valueCode value="CC-BY-4.0"/>
    </extension>
    <extension url="http://hl7.org/fhir/StructureDefinition/package-source">
      <extension url="packageId">
        <valueId value="de.medizininformatikinitiative.kerndatensatz.studie"/>
      </extension>
      <extension url="version">
        <valueString value="2027.0.0-ballot"/>
      </extension>
      <extension url="uri">
        <valueUri
                  value="https://www.medizininformatik-initiative.de/fhir/modul-studie"/>
      </extension>
    </extension>
    <profile
             value="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablecodesystem"/>
    <profile
             value="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablecodesystem"/>
  </meta>
  <language value="de"/>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm">
    <valueCoding>
      <system value="http://hl7.org/fhir/version-algorithm"/>
      <code value="semver"/>
      <display value="SemVer"/>
    </valueCoding>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability">
    <valueCode value="shareable"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability">
    <valueCode value="publishable"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy">
    <valueCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes"/>
        <version value="3.0.0"/>
        <code value="package"/>
        <display value="Package"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/resource-approvalDate">
    <valueDate value="2026-01-09"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod">
    <valuePeriod>
      <start value="2027"/>
    </valuePeriod>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-topic">
    <valueCodeableConcept>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
        <code value="C15206"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-topic">
    <valueCodeableConcept>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
        <code value="C15429"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
    <valueContactDetail>
      <name value="Matthias Löbe"/>
      <telecom>
        <system value="email"/>
        <value value="matthias.loebe@imise.uni-leipzig.de"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
    <valueContactDetail>
      <name value="Taskforce Core Data Set"/>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
    <valueContactDetail>
      <name value="Thomas Debertshäuser"/>
      <telecom>
        <system value="email"/>
        <value value="thomas.debertshaeuser@charite.de"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
    <valueContactDetail>
      <name value="Margaux Gatrio"/>
      <telecom>
        <system value="email"/>
        <value value="margaux.gatrio@bih-charite.de"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-reviewer">
    <valueContactDetail>
      <name value="Interoperability Working Group"/>
      <telecom>
        <system value="url"/>
        <value
               value="https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-reviewer">
    <valueContactDetail>
      <name value="National Steering Committee"/>
      <telecom>
        <system value="url"/>
        <value
               value="https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-endorser">
    <valueContactDetail>
      <name value="Interoperability Working Group"/>
      <telecom>
        <system value="url"/>
        <value
               value="https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/artifact-endorser">
    <valueContactDetail>
      <name value="National Steering Committee"/>
      <telecom>
        <system value="url"/>
        <value
               value="https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"/>
      </telecom>
    </valueContactDetail>
  </extension>
  <url value="http://example.org/fhir/CodeSystem/research-study-category"/>
  <version value="2027.0.0-ballot"/>
  <name value="ResearchStudyCategoryCS"/>
  <title value="Research Study Category Code System"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-01-09"/>
  <publisher value="NUM-DIZ"/>
  <contact>
    <name value="NUM-DIZ"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.netzwerk-universitaetsmedizin.de"/>
    </telecom>
  </contact>
  <description
               value="High-level categories describing the overall type of a research study."/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="DE"/>
      <display value="Germany"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="4"/>
  <concept>
    <code value="interventional"/>
    <display value="Interventional study"/>
    <definition
                value="A study in which participants are assigned to receive one or more interventions so that outcomes can be evaluated."/>
  </concept>
  <concept>
    <code value="observational"/>
    <display value="Observational study"/>
    <definition
                value="A study in which biomedical or health outcomes are observed in a defined population without assignment of specific interventions."/>
  </concept>
  <concept>
    <code value="registry"/>
    <display value="Registry study"/>
    <definition
                value="A study primarily based on data collected in a registry (e.g. disease or quality registry)."/>
  </concept>
  <concept>
    <code value="other"/>
    <display value="Other"/>
    <definition
                value="Other study category not covered by the existing codes. Use with additional descriptive text."/>
  </concept>
</CodeSystem>