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

## : ICH M11 Amendment Scope Value Set Terminology

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    {
      "resourceType" : "ValueSet",
      "id" : "m11-study-amendment-scope-vs",
      "language" : "en",
      "text" : {
        "status" : "extensions",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet m11-study-amendment-scope-vs</b></p><a name=\"m11-study-amendment-scope-vs\"> </a><a name=\"hcm11-study-amendment-scope-vs\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-ncit-cs.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title=\"Version is not explicitly stated, which means it is fixed to the version provided in this specification\"> version &#x1F4E6;1.0.0-ballot2</span><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C68846\">C68846</a></td><td>Global</td><td>Covering or affecting the whole of a system.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C217026\">C217026</a></td><td>Not Global</td><td>Covering or affecting only a portion of the entire system.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C48660\">C48660</a></td><td>Not Applicable</td><td>Determination of a value is not relevant in the current context.</td></tr></table></li></ul></div>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
          "valueInteger" : 0
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
          "valueCode" : "brr"
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
          "valueCode" : "trial-use",
          "_valueCode" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
              }
            ]
          }
        }
      ],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs",
      "version" : "1.0.0-ballot2",
      "name" : "M11AmendmentScopeVS",
      "title" : "ICH M11 Amendment Scope Value Set Terminology",
      "status" : "active",
      "experimental" : false,
      "date" : "2026-04-09T17:15:23+10:00",
      "publisher" : "HL7 International / Biomedical Research and Regulation",
      "contact" : [
        {
          "name" : "HL7 International / Biomedical Research and Regulation",
          "telecom" : [
            {
              "system" : "url",
              "value" : "http://www.hl7.org/Special/committees/rcrim"
            },
            {
              "system" : "email",
              "value" : "UDP@HL7Vulcan.org"
            }
          ]
        }
      ],
      "description" : "Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format.\n\nThe M11 guidance to \"leave blank\" if not applicable has to be replaced by an explicit \"Not Applicable\"",
      "jurisdiction" : [
        {
          "coding" : [
            {
              "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
              "code" : "001",
              "display" : "World"
            }
          ]
        }
      ],
      "copyright" : "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
      "compose" : {
        "include" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "concept" : [
              {
                "code" : "C68846",
                "display" : "Global"
              },
              {
                "code" : "C217026",
                "display" : "Not Global"
              },
              {
                "code" : "C48660",
                "display" : "Not Applicable"
              }
            ]
          }
        ]
      }
    }