Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

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: IGBJ Protocol Narrative 5.1 - XML Representation

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<Composition xmlns="http://hl7.org/fhir">
  <id value="IGBJ-Narrative-5.1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-narratives"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition IGBJ-Narrative-5.1</b></p><a name="IGBJ-Narrative-5.1"> </a><a name="hcIGBJ-Narrative-5.1"> </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-m11-research-study-narratives.html">Research Study Narratives</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs b001}">Protocol narrative</span></p><p><b>date</b>: 2025-06-03 12:46:00+0000</p><p><b>author</b>: <a href="Organization-IGBJ-Organization.html">Organization Eli Lilly Japan K.K</a></p><p><b>title</b>: IGBJ Protocol Narrative 5.1</p></div>
  </text>
  <status value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs"/>
      <code value="b001"/>
      <display value="Protocol narrative"/>
    </coding>
  </type>
  <subject>🔗 
    <reference value="ResearchStudy/IGBJ-ResearchStudy"/>
  </subject>
  <date value="2025-06-03T12:46:00Z"/>
  <author>🔗 
    <reference value="Organization/IGBJ-Organization"/>
  </author>
  <title value="IGBJ Protocol Narrative 5.1"/>
  <section>
    <title value="5.1	Description of Trial Population and Rationale"/>
    <code>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
        <code value="C218548"/>
      </coding>
    </code>
    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml">Seventy-five patients may be enrolled in order to have at least 66 patients (at least 30 patients with T1DM and T2DM, respectively) complete the study. For purposes of this study, a completer is defined as a patient who completes both periods with evaluable primary outcome. If patients discontinue from the study before completion of both periods with evaluable primary outcome for any reason, the patient may be replaced to ensure 66 patients complete the study. The replacement patients will be assigned the same treatment sequence as the patients to be replaced and will complete that treatment sequence in its entirety. Replacement should not occur beyond 75 patients enrolled, if it is expected to have at least 66 patients complete the study. Eligibility of patients for the study will be based on the results of screening medical history, physical examination, vital signs, clinical laboratory tests, and ECG. The nature of any conditions present at the time of the physical examination and any preexisting conditions will be documented. Screening may occur up to 28 days prior to enrollment. Patients who are not enrolled within 28 days of screening may be subjected to an additional medical assessment and/or clinical measurements to confirm their eligibility. Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, are not permitted.</div>
    </text>
  </section>
</Composition>