Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : START HERE: Exemplar Research Study with narrative

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    <ResearchStudy xmlns="http://hl7.org/fhir">
      <id value="Exemplar-ResearchStudy-001"/>
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                 value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"/>
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      <language value="en"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: ResearchStudy Exemplar-ResearchStudy-001</b></p><a name="Exemplar-ResearchStudy-001"> </a><a name="hcExemplar-ResearchStudy-001"> </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">Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-m11-research-study-profile.html">M11 Research Study Profile</a></p></div><p><b>M11_ConfidentialityStatement</b>: All data is confidential</p><blockquote><p><b>M11 Research Study Extension</b></p><ul><li>originalProtocol: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218488}">Protocol Previously Amended See Summary of Changes Before the Table of Contents</span></li><li>versionDate: 2017-10-01</li></ul></blockquote><blockquote><p><b>M11_Approval</b></p><ul><li>approvalDate: 2017-10-05</li><li>signature: No display for Signature  (data:  )</li><li>signatureUrl: <a href="https://somelocation">https://somelocation</a></li><li>signatureMethod: electronic and wet ink copy</li></ul></blockquote><p><b>Narrative Elements</b>: <a href="Composition-Exemplar-Narrative.html">Composition Exemplar Protocol Narratives</a></p><p><b>Narrative Elements</b>: <a href="Composition-Exemplar-Narrative-2.1.html">Composition Exemplar Protocol Narrative 2.1</a></p><p><b>identifier</b>: Sponsor Protocol Identifier/ABC-Exemplar, EU CT Number/EU-1234, Other Regulatory or Clinical Trial Identifier/ERA1234, Amendment Identifier/ABC-Exemplar(a)</p><p><b>version</b>: (a)</p><p><b>title</b>: A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus</p><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207646}">Study Acronym</span></p><p><b>value</b>: Inhaled vs IM Exoticillin</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207615}">Brief Study Title</span></p><p><b>value</b>: A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients</p></blockquote><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style="display: none">*</td><td>Justification</td><td><a href="ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.html">ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar (use: usual, ); version = (a); status = active</a></td></tr></table><p><b>status</b>: Active</p><p><b>phase</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}">Phase III Trial</span></p><h3>Focus</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="MedicinalProductDefinition-Exemplar-MedicinalProduct.html">MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03</a></td></tr></table><p><b>condition</b>: <span title="Codes:{http://snomed.info/sct 1137328006}">Iatrogenic hypoglycaemia</span></p><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}">Clinical Study Sponsor</span></p><p><b>party</b>: <a href="Organization-Exemplar-Sponsor-Organization.html">Organization Exemplar Pharmaceuticals Co.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}">Clinical Study Sponsor</span></p><p><b>party</b>: <a href="Practitioner-Exemplar-Sponsor-Practitioner.html">Practitioner Dr Exemplar Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}">Study Co-Sponsor</span></p><p><b>party</b>: <a href="Organization-Exemplar-CoSponsor-Organization.html">Organization Exemplar Pharmazeutika GmBH.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}">Study Co-Sponsor</span></p><p><b>party</b>: <a href="Practitioner-Exemplar-CoSponsor-Practitioner.html">Practitioner Dr Exemplar von Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}">Local Legal Sponsor</span></p><p><b>party</b>: <a href="Organization-Exemplar-Local-Sponsor-Organization.html">Organization Fictive Pharmaceuticals (Australia) Pty</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}">Local Legal Sponsor</span></p><p><b>party</b>: <a href="Practitioner-Exemplar-Local-Sponsor-Practitioner.html">Practitioner Bruce Exemplar</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C156625}">Device Manufacturer</span></p><p><b>party</b>: <a href="Organization-Exemplar-Devices-Organization.html">Organization Exemplar Devices Ltd</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C51876}">Sponsor Medical Expert</span></p><p><b>party</b>: <a href="Practitioner-Exemplar-Sponsor-Expert-Practitioner.html">Practitioner Dr Exemplar Consultant</a></p></blockquote></div>
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        <extension url="versionDate">
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      <extension
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        <extension url="signature">
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                  value=" "/>
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        <extension url="signatureMethod">
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      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements">
        <valueReference>🔗
          <reference value="Composition/Exemplar-Narrative"/>
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      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements">
        <valueReference>🔗
          <reference value="Composition/Exemplar-Narrative-2.1"/>
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            <code value="C132351"/>
            <display value="Sponsor Protocol Identifier"/>
          </coding>
        </type>
        <system value="https://exemplarSponsor.com/sponsor-identifier"/>
        <value value="ABC-Exemplar"/>
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      <identifier>
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          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C218684"/>
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          <text value="EU CT Number"/>
        </type>
        <system value="https://exemplarEMA.org/registry-identifier"/>
        <value value="EU-1234"/>
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      <identifier>
        <type>
          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C218690"/>
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          <text value="Other Regulatory or Clinical Trial Identifier"/>
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        <system value="https://exemplarRegulator.org/registry-identifier"/>
        <value value="ERA1234"/>
        <assigner>🔗
          <reference value="Organization/Exemplar-Regulator-Organization"/>
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      <identifier>
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            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C218477"/>
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          <text value="Amendment Identifier"/>
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        <system value="https://example.org/amendment-identifier"/>
        <value value="ABC-Exemplar(a)"/>
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        <targetReference>🔗
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          <reference
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          <code value="1137328006"/>
          <display value="Iatrogenic hypoglycaemia"/>
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            <code value="C70793"/>
            <display value="Clinical Study Sponsor"/>
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        <party>🔗
          <reference value="Organization/Exemplar-Sponsor-Organization"/>
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          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
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            <display value="Clinical Study Sponsor"/>
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        <party>🔗
          <reference value="Practitioner/Exemplar-Sponsor-Practitioner"/>
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        <party>🔗
          <reference value="Organization/Exemplar-CoSponsor-Organization"/>
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          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
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        <party>🔗
          <reference value="Practitioner/Exemplar-CoSponsor-Practitioner"/>
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          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
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            <display value="Local Legal Sponsor"/>
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        <party>🔗
          <reference value="Organization/Exemplar-Local-Sponsor-Organization"/>
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      <associatedParty>
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          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
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            <display value="Device Manufacturer"/>
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        <party>🔗
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            <display value="Sponsor Medical Expert"/>
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        <party>🔗
          <reference value="Practitioner/Exemplar-Sponsor-Expert-Practitioner"/>
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      </associatedParty>
    </ResearchStudy>