MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot -
Germany
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
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<reference value="Organization/mii-exa-studie-custodian"/>
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<related>🔗
<reference value="ResearchStudy/mii-exa-studie-cohort"/>
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<url value="MII_PR_Studie_Dokument"/>
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<entry>
<fullUrl
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<id value="mii-exa-studie-ein-auschluss-kriterium"/>
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<reference
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<description value="Altersbeschränkung"/>
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<text value="Altersbeschränkung"/>
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<valueCanonical
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<description value="Geschlecht"/>
<definitionCodeableConcept>
<text value="Alle"/>
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<valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
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<description
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<description
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<characteristic>
<extension
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<extension url="code">
<valueCode value="any-of"/>
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<extension url="characteristic">
<valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
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<extension url="characteristic">
<valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/>
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<description value="Weitere Einschlusskriterien"/>
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<code value="unknown"/>
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<characteristic>
<description
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<definitionCodeableConcept>
<coding>
<system
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<code value="unknown"/>
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<exclude value="true"/>
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<characteristic>
<description
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<definitionCodeableConcept>
<coding>
<system
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<code value="unknown"/>
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<exclude value="true"/>
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<characteristic>
<description value="weitere neurologische Erkrankungen"/>
<definitionCodeableConcept>
<coding>
<system
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<code value="unknown"/>
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<exclude value="true"/>
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<characteristic>
<extension
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<extension url="type">
<valueCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="424144002"/>
<display value="Current chronological age"/>
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<extension url="value">
<valueQuantity>
<value value="18"/>
<comparator value=">="/>
<unit value="year"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</valueQuantity>
</extension>
</extension>
<description value="Alter mindestens 18 Jahre"/>
<definitionCodeableConcept>
<text value="Mindestalter"/>
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<exclude value="false"/>
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</EvidenceVariable>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_EinAuschlussKriterium"/>
</request>
</entry>
<entry>
<fullUrl
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<ResearchStudy>
<id value="mii-exa-studie-studie"/>
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<profile
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<code value="HTEST"/>
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<extension
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<code value="scientific"/>
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<extension url="type">
<valueCodeableConcept>
<text value="Öffentlicher Titel"/>
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<extension
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<valueString value="tDCS"/>
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<extension
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<extension url="rekrutierungsstart">
<valueDate value="2023-01-12"/>
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<extension url="rekrutierungsziel">
<valueInteger value="40"/>
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<extension url="rekrutierungsstand">
<valueInteger value="35"/>
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<extension url="rekrutierungsstand-genauigkeit">
<valueString value="good"/>
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<extension url="rekrutierungsstand-datum">
<valueDate value="2023-02-17"/>
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</extension>
<extension
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<valueString
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<extension
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<extension url="status">
<valueString value="Zustimmende Bewertung"/>
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<extension url="kommission">
<valueString
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<extension url="ethiknummer">
<valueString value="Az.: 83/18"/>
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<identifier>
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<value value="DRKS00031294"/>
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<title
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<category>
<coding>
<code value="interventional"/>
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<category>
<text value="Zufallszuteilung"/>
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<description
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<arm>
<name value="frontale anodale tDCS (verum condition)"/>
<description
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<arm>
<name value="frontale sham tDCS"/>
<description value="vier Stimulationen, jeweils 30 Minuten"/>
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</ResearchStudy>
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<request>
<method value="POST"/>
<url value="MII_PR_Studie_Studie"/>
</request>
</entry>
<entry>
<fullUrl
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<resource>
<ResearchStudy>
<id value="mii-exa-studie-cohort"/>
<meta>
<profile
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<security>
<system
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<code value="HTEST"/>
<display value="test health data"/>
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<language value="en"/>
<text>
<status value="extensions"/>
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<extension
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<extension url="value">
<valueString value="MII Modul Studie"/>
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<extension
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<extension url="role">
<valueCodeableConcept>
<coding>
<system
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<code value="sponsor"/>
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</extension>
<extension url="party">
<valueReference>🔗
<reference value="Organization/mii-exa-studie-author"/>
</valueReference>
</extension>
</extension>
<extension
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<extension url="status">
<valueString value="genehmigt"/>
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<extension url="kommission">
<valueString
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</extension>
<extension url="ethiknummer">
<valueString value="159-12-21052012"/>
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</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister">
<valueReference>🔗
<reference value="Library/mii-exa-studie-register"/>
</valueReference>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility">
<valueReference>🔗
<reference
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</valueReference>
</extension>
<extension
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<valueString value="LIFE ADULT"/>
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<extension
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<extension url="rekrutierungsstart">
<valueDate value="2009-01-01"/>
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<extension url="rekrutierungsziel">
<valueInteger value="10000"/>
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<extension url="rekrutierungsstand">
<valueInteger value="10000"/>
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<extension url="rekrutierungsstand-genauigkeit">
<valueString value="good"/>
</extension>
<extension url="rekrutierungsstand-datum">
<valueDate value="2022-05-28"/>
</extension>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung">
<valueString
value="Deutsches Bundesministerium für Bildung und Forschung (BMBF)"/>
</extension>
<identifier>
<system value="https://example.com/fhir/sid/lha"/>
<value value="7Q6PJD8NV3-2"/>
</identifier>
<title value="LIFE-Adult-Study"/>
<partOf>🔗
<reference value="ResearchStudy/mii-exa-studie-reference-study"/>
</partOf>
<status value="active"/>
<category>
<coding>
<system
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<code value="observational"/>
</coding>
</category>
<focus>
<text value="Erwachsene der Stadt Leipzig"/>
</focus>
<keyword>
<text value="Bevölkerung, Leipzig, Erwachsene"/>
</keyword>
<description
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<arm>
<name value="LIFE-Adult-Kohorte"/>
</arm>
</ResearchStudy>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_Cohort"/>
</request>
</entry>
<entry>
<fullUrl
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<ResearchSubject>
<id value="mii-exa-studie-proband"/>
<meta>
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<code value="HTEST"/>
<display value="test health data"/>
</security>
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<language value="en"/>
<text>
<status value="generated"/>
</text>
<identifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="ANON"/>
</coding>
</type>
<system
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<value value="321123456"/>
</identifier>
<status value="candidate"/>
<period>
<start value="2023-01-01"/>
<end value="2023-12-31"/>
</period>
<study>🔗
<reference value="ResearchStudy/mii-exa-studie-cohort"/>
</study>
<individual>🔗
<reference value="Patient/mii-exa-studie-patient"/>
</individual>
<consent>🔗
<reference value="Consent/mii-exa-studie-consent"/>
</consent>
</ResearchSubject>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_Proband"/>
</request>
</entry>
<entry>
<fullUrl
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<resource>
<PractitionerRole>
<id value="mii-exa-studie-beteiligte-person"/>
<meta>
<profile
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<security>
<system
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<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<practitioner>🔗
<reference value="Practitioner/mii-exa-studie-practitioner"/>
</practitioner>
<organization>🔗
<reference
value="Organization/mii-exa-studie-practitioner-organization"/>
</organization>
<code>
<coding>
<system
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<code value="doctor"/>
</coding>
</code>
<telecom>
<system value="phone"/>
<value value="0123456789"/>
</telecom>
</PractitionerRole>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_Beteiligte_Person"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Register/mii-exa-studie-register"/>
<resource>
<Library>
<id value="mii-exa-studie-register"/>
<meta>
<profile
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<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<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>
</text>
<identifier>
<system value="https://example.com/fhir/sid/drks"/>
<value value="DRKS"/>
</identifier>
<name value="DRKS - Deutsches Register Klinischer Studien"/>
<status value="active"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/library-type"/>
<code value="asset-collection"/>
</coding>
</type>
<relatedArtifact>
<type value="documentation"/>
<url value="https://drks.de/"/>
<document>
<url value="https://drks.de/"/>
</document>
</relatedArtifact>
</Library>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_Register"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-author"/>
<resource>
<Organization>
<id value="mii-exa-studie-author"/>
<meta>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<name value="Example Organization for Author"/>
</Organization>
</resource>
<request>
<method value="POST"/>
<url value="Organization"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-custodian"/>
<resource>
<Organization>
<id value="mii-exa-studie-custodian"/>
<meta>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<name value="Example Organization for Custodian"/>
</Organization>
</resource>
<request>
<method value="POST"/>
<url value="Organization"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-practitioner-organization"/>
<resource>
<Organization>
<id value="mii-exa-studie-practitioner-organization"/>
<meta>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<name value="Example Organization for Practitioner"/>
</Organization>
</resource>
<request>
<method value="POST"/>
<url value="Organization"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/Practitioner/mii-exa-studie-practitioner"/>
<resource>
<Practitioner>
<id value="mii-exa-studie-practitioner"/>
<meta>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<name>
<family value="Mustermann"/>
<given value="Max"/>
</name>
</Practitioner>
</resource>
<request>
<method value="POST"/>
<url value="Practitioner"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/ResearchStudy/mii-exa-studie-reference-study"/>
<resource>
<ResearchStudy>
<id value="mii-exa-studie-reference-study"/>
<meta>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<title value="Example Reference Study"/>
<status value="completed"/>
</ResearchStudy>
</resource>
<request>
<method value="POST"/>
<url value="ResearchStudy"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/Patient/mii-exa-studie-patient"/>
<resource>
<Patient>
<id value="mii-exa-studie-patient"/>
<meta>
<profile
value="http://fhir.de/ConsentManagement/StructureDefinition/Patient"/>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<identifier>
<use value="official"/>
<type>
<coding>
<system
value="http://fhir.de/CodeSystem/identifier-type-de-basis"/>
<code value="KVZ10"/>
</coding>
</type>
<system value="http://fhir.de/sid/gkv/kvid-10"/>
<value value="D92345678"/>
</identifier>
<name>
<family value="Doe"/>
<given value="Jane"/>
</name>
<gender value="female"/>
<birthDate value="1980-11-12"/>
<deceasedBoolean value="false"/>
</Patient>
</resource>
<request>
<method value="POST"/>
<url value="Patient"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/Consent/mii-exa-studie-consent"/>
<resource>
<Consent>
<id value="mii-exa-studie-consent"/>
<meta>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
</text>
<status value="active"/>
<scope>
<coding>
<code value="research"/>
</coding>
</scope>
<category>
<coding>
<system value="http://loinc.org"/>
<code value="59284-0"/>
</coding>
</category>
<patient>🔗
<reference value="Patient/mii-exa-studie-patient"/>
</patient>
<policy>
<uri value="urn:oid:2.16.840.1.113883.3.1937.777.24.2.1791"/>
</policy>
</Consent>
</resource>
<request>
<method value="POST"/>
<url value="Consent"/>
</request>
</entry>
</Bundle>