HL7 Terminology (THO)
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: ICH Context of Use - XML Representation

Active as of 2025-03-24

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<NamingSystem xmlns="http://hl7.org/fhir">
  <id value="ICHContextOfUse"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: NamingSystem ICHContextOfUse</b></p><a name="ICHContextOfUse"> </a><a name="hcICHContextOfUse"> </a><a name="ICHContextOfUse-en-US"> </a><h3>Summary</h3><table class="grid"><tr><td>Defining URL</td><td>http://terminology.hl7.org/NamingSystem/ICHContextOfUse</td></tr><tr><td>Version</td><td>1.1.0</td></tr><tr><td>Name</td><td>ICHContextOfUse</td></tr><tr><td>Title</td><td>ICH Context of Use</td></tr><tr><td>Status</td><td>active</td></tr><tr><td>Definition</td><td><div><p>Codes are found within the vocabulary package at the link above which is available from this page: <a href="https://ich.org/page/ich-electronic-common-technical-document-ectd-v40">https://ich.org/page/ich-electronic-common-technical-document-ectd-v40</a>. Specifically, the codes are in the “ICH Context of Use” tab of the &quot;ICH M8 OID Listing_eCTDv4_v5.xlsx&quot; workbook. The codes are part of the ICH implementation of HL7 V3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2 Normative (described here: <a href="https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38">https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38</a>)</p>
<p>When using this uri in FHIR, the version identifier is mandatory and the code system uri cannot be used without it.</p>
<p>This system uses an integer based versioning system in conjunction with an OID update. For example, if the version of the system is v5, the OID is 2.16.840.1.113883.3.989.2.2.1.1.5. This system has an OID stem of 2.16.840.1.113883.3.989.2.2.1.1.</p>
</div></td></tr><tr><td>Publisher</td><td>International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)</td></tr></table><h3>Identifiers</h3><table class="grid"><tr><td><b>Type</b></td><td><b>Value</b></td><td><b>Preferred</b></td><td><b>Period</b></td><td><b>Comment</b></td></tr><tr><td>URI</td><td>http://terminology.hl7.org/CodeSystem/ICHContextOfUse</td><td>true</td><td>2025-03-24 --&gt; (ongoing)</td><td>This is the official uri endorsed by TSMG.</td></tr><tr><td>URI</td><td>http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use</td><td>false</td><td>2024-12-12 --&gt; 2025-03-24</td><td>This was a temporary uri assigned by TSMG. This should be replaced with the official uri.</td></tr></table></div>
  </text>
  <url value="http://terminology.hl7.org/NamingSystem/ICHContextOfUse"/>
  <version value="1.1.0"/>
  <name value="ICHContextOfUse"/>
  <title value="ICH Context of Use"/>
  <status value="active"/>
  <kind value="codesystem"/>
  <date value="2025-03-24T00:00:00-00:00"/>
  <publisher
             value="International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)"/>
  <contact>
    <name
          value="International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH); Route de Pré-Bois, 20; P.O Box 1894; 1215 Geneva; Switzerland"/>
    <telecom>
      <system value="url"/>
      <value value="https://ich.org/"/>
    </telecom>
    <telecom>
      <system value="url"/>
      <value value="https://ich.org/page/contact-form"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="admin@ich.org"/>
    </telecom>
  </contact>
  <responsible
               value="International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)"/>
  <description
               value="Codes are found within the vocabulary package at the link above which is available from this page: [https://ich.org/page/ich-electronic-common-technical-document-ectd-v40](https://ich.org/page/ich-electronic-common-technical-document-ectd-v40). Specifically, the codes are in the “ICH Context of Use” tab of the &quot;ICH M8 OID Listing_eCTDv4_v5.xlsx&quot; workbook. The codes are part of the ICH implementation of HL7 V3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2 Normative (described here: [https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38](https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38))

When using this uri in FHIR, the version identifier is mandatory and the code system uri cannot be used without it.

This system uses an integer based versioning system in conjunction with an OID update. For example, if the version of the system is v5, the OID is 2.16.840.1.113883.3.989.2.2.1.1.5. This system has an OID stem of 2.16.840.1.113883.3.989.2.2.1.1."/>
  <uniqueId>
    <type value="uri"/>
    <value value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
    <preferred value="true"/>
    <comment value="This is the official uri endorsed by TSMG."/>
    <period>
      <start value="2025-03-24"/>
    </period>
  </uniqueId>
  <uniqueId>
    <type value="uri"/>
    <value
           value="http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"/>
    <preferred value="false"/>
    <comment
             value="This was a temporary uri assigned by TSMG. This should be replaced with the official uri."/>
    <period>
      <start value="2024-12-12"/>
      <end value="2025-03-24"/>
    </period>
  </uniqueId>
</NamingSystem>