# ICH M11 Amendment Scope Value Set Terminology - Clinical Study Protocol v1.0.0-ballot2

## ValueSet: ICH M11 Amendment Scope Value Set Terminology 

 
Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format. 
The M11 guidance to "leave blank" if not applicable has to be replaced by an explicit "Not Applicable" 

 **References** 

* [M11_ProtocolAmendment](StructureDefinition-m11-protocol-amendment.md)

### Logical Definition (CLD)

 

### Expansion

-------

 [Description of the above table(s)](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#terminology). 



## Resource Content

```json
{
  "resourceType" : "ValueSet",
  "id" : "m11-study-amendment-scope-vs",
  "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"
      }]
    }]
  }
}

```
