Clinical Study Protocol, 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-ballot2 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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: ICH M11 Study Amendment Country Value Set

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="m11-country-region-vs"/>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet m11-country-region-vs</b></p><a name="m11-country-region-vs"> </a><a name="hcm11-country-region-vs"> </a><p>This value set includes codes based on the following rules:</p><ul><li>Import all the codes that are contained in <a href="http://hl7.org/fhir/R5/valueset-iso3166-1-2.html">Iso 3166 Part 1: 2 Letter Codes</a></li><li>Import all the codes that are contained in <a href="http://hl7.org/fhir/R5/valueset-iso3166-1-3.html">Iso 3166 Part 1: 3 Letter Codes</a></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="M11CountryRegionVS"/>
  <title value="ICH M11 Study Amendment Country Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-08T21:09:32+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
    </telecom>
  </contact>
  <description
               value="Codes drawn from 
ISO 3166 Country Codes, Alpha 3; 
ISO 3166 Country Codes, Alpha 2; 
country/region codes. This is ICH M11 Value Set represented here in FHIR format."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <copyright
             value="Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. 
The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. 

CDISC publishes semantics for the ICH M11 protocol data elements and valid 
value sets. This terminology set is published and stored in the NCI Thesaurus 
Subset C217023 - ICH M11 Terminology 
(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) 

The NCI Thesaurus is released under the CC BY 4.0 license

For more licensing information and links see: [licenses.html](licenses.html)"/>
  <compose>
    <include>
      <valueSet value="http://hl7.org/fhir/ValueSet/iso3166-1-2"/>
    </include>
    <include>
      <valueSet value="http://hl7.org/fhir/ValueSet/iso3166-1-3"/>
    </include>
  </compose>
</ValueSet>