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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<timestamp value="2025-12-04T12:00:00+00:00"/>
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<id value="mii-exa-studie-dokument"/>
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<div xml:lang="de" lang="de"><hr/><p><b>German</b></p><hr/><p class="res-header-id"><b>Generated Narrative: DocumentReference mii-exa-studie-dokument</b></p><a name="mii-exa-studie-dokument"> </a><a name="hcmii-exa-studie-dokument"> </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">Profile: <a href="StructureDefinition-mii-pr-studie-dokument.html">MII PR Studie Dokument</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>status</b>: Current</p><p><b>author</b>: <a href="Organization-mii-exa-studie-author.html">Organization Example Organization for Author</a></p><p><b>custodian</b>: <a href="Organization-mii-exa-studie-custodian.html">Organization Example Organization for Custodian</a></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td></tr><tr><td style="display: none">*</td><td>pdf</td><td><a href="https://example.com/fhir/Binary/document">https://example.com/fhir/Binary/document</a></td><td>2000</td><td>Beispiel Dokument</td></tr></table></blockquote><h3>Contexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Related</b></td></tr><tr><td style="display: none">*</td><td><a href="ResearchStudy-mii-exa-studie-cohort.html">ResearchStudy LIFE-Adult-Study</a></td></tr></table></div>
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<author>🔗
<reference value="Organization/mii-exa-studie-author"/>
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<reference value="Organization/mii-exa-studie-custodian"/>
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<content>
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<contentType value="application/pdf"/>
<url value="https://example.com/fhir/Binary/document"/>
<size value="2000"/>
<title value="Beispiel Dokument"/>
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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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<resource>
<EvidenceVariable>
<id value="mii-exa-studie-ein-auschluss-kriterium"/>
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<profile
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<code value="HTEST"/>
<display value="test health data"/>
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<language value="de"/>
<text>
<status value="extensions"/>
<div xml:lang="de" lang="de"><hr/><p><b>German</b></p><hr/><p class="res-header-id"><b>Generated Narrative: EvidenceVariable mii-exa-studie-ein-auschluss-kriterium</b></p><a name="mii-exa-studie-ein-auschluss-kriterium"> </a><a name="hcmii-exa-studie-ein-auschluss-kriterium"> </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">Profile: <a href="StructureDefinition-mii-pr-studie-ein-auschluss-kriterium.html">MII PR Studie EinAuschlussKriterium</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>status</b>: Active</p><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport definitionReference</b>: <a href="EvidenceVariable-mii-exa-studie-evidence-variable-age-restriction.html">EvidenceVariable: status = active</a></p><p><b>description</b>: Altersbeschränkung</p><p><b>definition</b>: <span title="Codes:">Altersbeschränkung</span></p></blockquote><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport definitionCanonical</b>: <code>https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender</code></p><p><b>description</b>: Geschlecht</p><p><b>definition</b>: <span title="Codes:">Alle</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport linkId</b>: aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2</p><p><b>description</b>: Kognitive Fatigue (WeiMUS kognitive Skala >= 17)</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>MII EX Studie Backport linkId</b>: 8e8f63ff-65f1-40cd-bf79-da83d7fb4e09</p><p><b>description</b>: Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><blockquote><p><b>MII EX Studie Backport DefinitionByCombination</b></p><ul><li>code: any-of</li><li>characteristic: aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2</li><li>characteristic: 8e8f63ff-65f1-40cd-bf79-da83d7fb4e09</li></ul></blockquote><p><b>description</b>: Weitere Einschlusskriterien</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>description</b>: diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>description</b>: Einnahme von Antidepressiva, Opioiden, Antikonvulsiva</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>description</b>: weitere neurologische Erkrankungen</p><p><b>definition</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/data-absent-reason unknown}">Unknown</span></p><p><b>exclude</b>: true</p></blockquote><blockquote><p><b>characteristic</b></p><blockquote><p><b>MII EX Studie Backport DefinitionByTypeAndValue</b></p><ul><li>type: <span title="Codes:{http://snomed.info/sct 424144002}">Current chronological age</span></li><li>value: >=18 year<span style="background: LightGoldenRodYellow"> (Details: UCUM codea = 'a')</span></li></ul></blockquote><p><b>description</b>: Alter mindestens 18 Jahre</p><p><b>definition</b>: <span title="Codes:">Mindestalter</span></p><p><b>exclude</b>: false</p></blockquote></div>
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<description value="Altersbeschränkung"/>
<definitionCodeableConcept>
<text value="Altersbeschränkung"/>
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url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.definitionCanonical">
<valueCanonical
value="https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender"/>
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<description value="Geschlecht"/>
<definitionCodeableConcept>
<text value="Alle"/>
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<exclude value="false"/>
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<characteristic>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-EvidenceVariable.characteristic.linkId">
<valueId value="aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2"/>
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<description
value="Kognitive Fatigue (WeiMUS kognitive Skala >= 17)"/>
<definitionCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/data-absent-reason"/>
<code value="unknown"/>
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<exclude value="false"/>
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<valueId value="8e8f63ff-65f1-40cd-bf79-da83d7fb4e09"/>
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<description
value="Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt"/>
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<system
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<code value="unknown"/>
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<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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<characteristic>
<description
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<code value="unknown"/>
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<description
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<code value="unknown"/>
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<description value="weitere neurologische Erkrankungen"/>
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<code value="unknown"/>
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<extension url="type">
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<coding>
<system value="http://snomed.info/sct"/>
<code value="424144002"/>
<display value="Current chronological age"/>
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<valueQuantity>
<value value="18"/>
<comparator value=">="/>
<unit value="year"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
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<description value="Alter mindestens 18 Jahre"/>
<definitionCodeableConcept>
<text value="Mindestalter"/>
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<exclude value="false"/>
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<method value="POST"/>
<url value="MII_PR_Studie_EinAuschlussKriterium"/>
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<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Studie/mii-exa-studie-studie"/>
<resource>
<ResearchStudy>
<id value="mii-exa-studie-studie"/>
<meta>
<profile
value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"/>
<security>
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value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="de"/>
<text>
<status value="extensions"/>
<div xml:lang="de" lang="de"><hr/><p><b>German</b></p><hr/><p class="res-header-id"><b>Generated Narrative: ResearchStudy mii-exa-studie-studie</b></p><a name="mii-exa-studie-studie"> </a><a name="hcmii-exa-studie-studie"> </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">Profile: <a href="StructureDefinition-mii-pr-studie-studie.html">MII PR Studie Studie</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><blockquote><p><b>MII EX Studie Backport Label</b></p><ul><li>value: Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue</li><li>type: <span title="Codes:{http://terminology.hl7.org/CodeSystem/title-type scientific}">Scientific title</span></li></ul></blockquote><blockquote><p><b>MII EX Studie Backport Label</b></p><ul><li>value: Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue</li><li>type: <span title="Codes:">Öffentlicher Titel</span></li></ul></blockquote><p><b>MII EX Studie Akronym</b>: tDCS</p><blockquote><p><b>MII EX Studie Rekrutierung</b></p><ul><li>rekrutierungsstart: 2023-01-12</li><li>rekrutierungsziel: 40</li><li>rekrutierungsstand: 35</li><li>rekrutierungsstand-genauigkeit: good</li><li>rekrutierungsstand-datum: 2023-02-17</li></ul></blockquote><p><b>MII EX Studie Finanzierung</b>: Öffentliche Förderinstitutionen, aus Steuermitteln getragene Institutionen (DFG, BMBF u. a.)</p><blockquote><p><b>MII EX Studie Ethikvotum</b></p><ul><li>status: Zustimmende Bewertung</li><li>kommission: Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.</li><li>ethiknummer: Az.: 83/18</li></ul></blockquote><p><b>identifier</b>: <code>https://example.com/fhir/sid/drks</code>/DRKS00031294</p><p><b>title</b>: Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue</p><p><b>status</b>: Active</p><p><b>category</b>: <span title="Codes:">interventional</span>, <span title="Codes:">Zufallszuteilung</span></p><p><b>description</b>: </p><div><p>Diese Studie untersucht den Einfluss repetitiver anodaler Gleichstromstimulation des linken dorsolateralen präfrontalen Kortex (dlPFC ) auf subjektive und objektive Kennwerte und assoziierte EEG-Parameter der Fatigue bei Long-COVID Patient*innen. Die Studie ist sham-kontrolliert und doppelt-verblindet.</p>
</div><blockquote><p><b>arm</b></p><p><b>name</b>: frontale anodale tDCS (verum condition)</p><p><b>description</b>: vier Stimulationen, jeweils 30 Minuten, 1.5mA über dem linken dlPFC</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: frontale sham tDCS</p><p><b>description</b>: vier Stimulationen, jeweils 30 Minuten</p></blockquote></div>
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<coding>
<system
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<code value="scientific"/>
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<extension
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<extension url="value">
<valueString
value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<text value="Öffentlicher Titel"/>
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</extension>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym">
<valueString value="tDCS"/>
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<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung">
<extension url="rekrutierungsstart">
<valueDate value="2023-01-12"/>
</extension>
<extension url="rekrutierungsziel">
<valueInteger value="40"/>
</extension>
<extension url="rekrutierungsstand">
<valueInteger value="35"/>
</extension>
<extension url="rekrutierungsstand-genauigkeit">
<valueString value="good"/>
</extension>
<extension url="rekrutierungsstand-datum">
<valueDate value="2023-02-17"/>
</extension>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung">
<valueString
value="Öffentliche Förderinstitutionen, aus Steuermitteln getragene Institutionen (DFG, BMBF u. a.)"/>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum">
<extension url="status">
<valueString value="Zustimmende Bewertung"/>
</extension>
<extension url="kommission">
<valueString
value="Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R."/>
</extension>
<extension url="ethiknummer">
<valueString value="Az.: 83/18"/>
</extension>
</extension>
<identifier>
<system value="https://example.com/fhir/sid/drks"/>
<value value="DRKS00031294"/>
</identifier>
<title
value="Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue"/>
<status value="active"/>
<category>
<coding>
<code value="interventional"/>
</coding>
</category>
<category>
<text value="Zufallszuteilung"/>
</category>
<description
value="Diese Studie untersucht den Einfluss repetitiver anodaler Gleichstromstimulation des linken dorsolateralen präfrontalen Kortex (dlPFC ) auf subjektive und objektive Kennwerte und assoziierte EEG-Parameter der Fatigue bei Long-COVID Patient*innen. Die Studie ist sham-kontrolliert und doppelt-verblindet."/>
<arm>
<name value="frontale anodale tDCS (verum condition)"/>
<description
value="vier Stimulationen, jeweils 30 Minuten, 1.5mA über dem linken dlPFC"/>
</arm>
<arm>
<name value="frontale sham tDCS"/>
<description value="vier Stimulationen, jeweils 30 Minuten"/>
</arm>
</ResearchStudy>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_Studie"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Cohort/mii-exa-studie-cohort"/>
<resource>
<ResearchStudy>
<id value="mii-exa-studie-cohort"/>
<meta>
<profile
value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie"/>
<security>
<system
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<code value="HTEST"/>
<display value="test health data"/>
</security>
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<language value="de"/>
<text>
<status value="extensions"/>
<div xml:lang="de" lang="de"><hr/><p><b>German</b></p><hr/><p class="res-header-id"><b>Generated Narrative: ResearchStudy mii-exa-studie-cohort</b></p><a name="mii-exa-studie-cohort"> </a><a name="hcmii-exa-studie-cohort"> </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">Profile: <a href="StructureDefinition-mii-pr-studie-studie.html">MII PR Studie Studie</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><blockquote><p><b>MII EX Studie Backport Label</b></p><ul><li>value: MII Modul Studie</li></ul></blockquote><blockquote><p><b>MII EX Studie Backport AssociatedParty</b></p><ul><li>role: <span title="Codes:{http://example.org/fhir/CodeSystem/associated-party-role sponsor}">Sponsor</span></li><li>party: <a href="Organization-mii-exa-studie-author.html">Organization Example Organization for Author</a></li></ul></blockquote><blockquote><p><b>MII EX Studie Ethikvotum</b></p><ul><li>status: genehmigt</li><li>kommission: Ethik-Kommission der Medizinischen Fakultät der Universität Leipzig</li><li>ethiknummer: 159-12-21052012</li></ul></blockquote><p><b>MII EX Studie Studienregister</b>: <a href="Library-mii-exa-studie-register.html">DRKS - Deutsches Register Klinischer Studien</a></p><p><b>MII EX Studie Eligibility</b>: <a href="EvidenceVariable-mii-exa-studie-ein-auschluss-kriterium.html">EvidenceVariable: status = active</a></p><p><b>MII EX Studie Akronym</b>: LIFE ADULT</p><blockquote><p><b>MII EX Studie Rekrutierung</b></p><ul><li>rekrutierungsstart: 2009-01-01</li><li>rekrutierungsziel: 10000</li><li>rekrutierungsstand: 10000</li><li>rekrutierungsstand-genauigkeit: good</li><li>rekrutierungsstand-datum: 2022-05-28</li></ul></blockquote><p><b>MII EX Studie Finanzierung</b>: Deutsches Bundesministerium für Bildung und Forschung (BMBF)</p><p><b>identifier</b>: <code>https://example.com/fhir/sid/lha</code>/7Q6PJD8NV3-2</p><p><b>title</b>: LIFE-Adult-Study</p><p><b>partOf</b>: <a href="ResearchStudy-mii-exa-studie-reference-study.html">ResearchStudy Example Reference Study</a></p><p><b>status</b>: Active</p><p><b>category</b>: <span title="Codes:{http://example.org/fhir/CodeSystem/research-study-category observational}">Observational study</span></p><p><b>focus</b>: <span title="Codes:">Erwachsene der Stadt Leipzig</span></p><p><b>keyword</b>: <span title="Codes:">Bevölkerung, Leipzig, Erwachsene</span></p><p><b>description</b>: </p><div><p>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 charakterisiert. Bisher unbekannte Risikofaktoren für die Entstehung von Volkskrankheiten sollen aufgespürt und neue Möglichkeiten der Früherkennung entwickelt werden.</p>
</div><h3>Arms</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>LIFE-Adult-Kohorte</td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">
<extension url="value">
<valueString value="MII Modul Studie"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty">
<extension url="role">
<valueCodeableConcept>
<coding>
<system
value="http://example.org/fhir/CodeSystem/associated-party-role"/>
<code value="sponsor"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="party">
<valueReference>🔗
<reference value="Organization/mii-exa-studie-author"/>
</valueReference>
</extension>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum">
<extension url="status">
<valueString value="genehmigt"/>
</extension>
<extension url="kommission">
<valueString
value="Ethik-Kommission der Medizinischen Fakultät der Universität Leipzig"/>
</extension>
<extension url="ethiknummer">
<valueString value="159-12-21052012"/>
</extension>
</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
value="EvidenceVariable/mii-exa-studie-ein-auschluss-kriterium"/>
</valueReference>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym">
<valueString value="LIFE ADULT"/>
</extension>
<extension
url="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung">
<extension url="rekrutierungsstart">
<valueDate value="2009-01-01"/>
</extension>
<extension url="rekrutierungsziel">
<valueInteger value="10000"/>
</extension>
<extension url="rekrutierungsstand">
<valueInteger value="10000"/>
</extension>
<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
value="http://example.org/fhir/CodeSystem/research-study-category"/>
<code value="observational"/>
</coding>
</category>
<focus>
<text value="Erwachsene der Stadt Leipzig"/>
</focus>
<keyword>
<text value="Bevölkerung, Leipzig, Erwachsene"/>
</keyword>
<description
value="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 charakterisiert. Bisher unbekannte Risikofaktoren für die Entstehung von Volkskrankheiten sollen aufgespürt und neue Möglichkeiten der Früherkennung entwickelt werden."/>
<arm>
<name value="LIFE-Adult-Kohorte"/>
</arm>
</ResearchStudy>
</resource>
<request>
<method value="POST"/>
<url value="MII_PR_Studie_Cohort"/>
</request>
</entry>
<entry>
<fullUrl
value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Proband/mii-exa-studie-proband"/>
<resource>
<ResearchSubject>
<id value="mii-exa-studie-proband"/>
<meta>
<profile
value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-proband"/>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</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: ResearchSubject mii-exa-studie-proband</b></p><a name="mii-exa-studie-proband"> </a><a name="hcmii-exa-studie-proband"> </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">Profile: <a href="StructureDefinition-mii-pr-studie-proband.html">MII PR Studie Proband</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>identifier</b>: Anonymous identifier/321123456</p><p><b>status</b>: Candidate</p><p><b>period</b>: 2023-01-01 --> 2023-12-31</p><p><b>study</b>: <a href="ResearchStudy-mii-exa-studie-cohort.html">ResearchStudy LIFE-Adult-Study</a></p><p><b>individual</b>: <a href="Patient-mii-exa-studie-patient.html">Jane Doe Female, DoB: 1980-11-12 ( Krankenversichertennummer (use: official, ))</a></p><p><b>consent</b>: <a href="Consent-mii-exa-studie-consent.html">mii-exa-studie-consent</a></p></div>
</text>
<identifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="ANON"/>
</coding>
</type>
<system
value="https://www.medizininformatik-initiative.de/fhir/sid/patienten"/>
<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
value="https://www.medizininformatik-initiative.de/MII_PR_Studie_Beteiligte_Person/mii-exa-studie-beteiligte-person"/>
<resource>
<PractitionerRole>
<id value="mii-exa-studie-beteiligte-person"/>
<meta>
<profile
value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-beteiligte-person"/>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</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: PractitionerRole mii-exa-studie-beteiligte-person</b></p><a name="mii-exa-studie-beteiligte-person"> </a><a name="hcmii-exa-studie-beteiligte-person"> </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">Profile: <a href="StructureDefinition-mii-pr-studie-beteiligte-person.html">MII PR Studie Beteiligte Person</a></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>practitioner</b>: <a href="Practitioner-mii-exa-studie-practitioner.html">Practitioner Max Mustermann </a></p><p><b>organization</b>: <a href="Organization-mii-exa-studie-practitioner-organization.html">Organization Example Organization for Practitioner</a></p><p><b>code</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/practitioner-role doctor}">Doctor</span></p><p><b>telecom</b>: ph: 0123456789</p></div>
</text>
<practitioner>🔗
<reference value="Practitioner/mii-exa-studie-practitioner"/>
</practitioner>
<organization>🔗
<reference
value="Organization/mii-exa-studie-practitioner-organization"/>
</organization>
<code>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/practitioner-role"/>
<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
value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-register"/>
<security>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ActReason"/>
<code value="HTEST"/>
<display value="test health data"/>
</security>
</meta>
<language value="de"/>
<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="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: Organization mii-exa-studie-author</b></p><a name="mii-exa-studie-author"> </a><a name="hcmii-exa-studie-author"> </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">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>name</b>: Example Organization for Author</p></div>
</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="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: Organization mii-exa-studie-custodian</b></p><a name="mii-exa-studie-custodian"> </a><a name="hcmii-exa-studie-custodian"> </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">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>name</b>: Example Organization for Custodian</p></div>
</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="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: Organization mii-exa-studie-practitioner-organization</b></p><a name="mii-exa-studie-practitioner-organization"> </a><a name="hcmii-exa-studie-practitioner-organization"> </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">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>name</b>: Example Organization for Practitioner</p></div>
</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="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: Practitioner mii-exa-studie-practitioner</b></p><a name="mii-exa-studie-practitioner"> </a><a name="hcmii-exa-studie-practitioner"> </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">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>name</b>: Max Mustermann </p></div>
</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="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: ResearchStudy mii-exa-studie-reference-study</b></p><a name="mii-exa-studie-reference-study"> </a><a name="hcmii-exa-studie-reference-study"> </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">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p><b>title</b>: Example Reference Study</p><p><b>status</b>: Completed</p></div>
</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="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: Patient mii-exa-studie-patient</b></p><a name="mii-exa-studie-patient"> </a><a name="hcmii-exa-studie-patient"> </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">Profile: <code>http://fhir.de/ConsentManagement/StructureDefinition/Patient</code></p><p style="margin-bottom: 0px">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><p style="border: 1px #661aff solid; background-color: #e6e6ff; padding: 10px;">Jane Doe Female, DoB: 1980-11-12 ( Krankenversichertennummer (use: official, ))</p><hr/><table class="grid"><tr><td style="background-color: #f3f5da" title="Known status of Patient">Deceased:</td><td colspan="3">false</td></tr></table></div>
</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="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: Consent mii-exa-studie-consent</b></p><a name="mii-exa-studie-consent"> </a><a name="hcmii-exa-studie-consent"> </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">Security Label: <a href="http://terminology.hl7.org/7.3.0/CodeSystem-v3-ActReason.html">test health data (Details: ActReason code HTEST = 'test health data')</a></p></div><h2>Participants</h2><table class="grid"><tr><td><b>Role</b></td><td><b>Details</b></td></tr><tr><td title="Who the consent applies to">Patient</td><td><a href="Patient-mii-exa-studie-patient.html">Jane Doe Female, DoB: 1980-11-12 ( Krankenversichertennummer (use: official, ))</a></td></tr></table><p>This consent is made under the policy <code>urn:oid:2.16.840.1.113883.3.1937.777.24.2.1791</code> .</p><p>The subject has given their consent.</p></div>
</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>