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

## ValueSet: ICH M11 Amendment Details Statement Value Set Terminology 

 
Terminology associated with whether or not a protocol has been amended. This is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format. 

 **References** 

* [M11_ProtocolAmendment](StructureDefinition-m11-protocol-amendment.md)
* [M11 Research Study Extension](StructureDefinition-m11-research-study.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-amendment-details-statement-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-amendment-details-statement-vs",
  "version" : "1.0.0-ballot2",
  "name" : "M11AmendmentDetailsStatementVS",
  "title" : "ICH M11 Amendment Details Statement 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 whether or not a protocol has been amended.\nThis is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format.",
  "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" : "C218486",
        "display" : "First Protocol Amendment"
      },
      {
        "code" : "C218485",
        "display" : "Protocol Not Amended"
      },
      {
        "code" : "C218488",
        "display" : "Protocol Previously Amended See Summary of Changes Before the Table of Contents"
      },
      {
        "code" : "C218487",
        "display" : "Protocol Previously Amended, Details Presented"
      }]
    }]
  }
}

```
