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Source1

{
  "resourceType": "ValueSet",
  "id": "ich-m11-amendment-reason",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "cds"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use"
    }
  ],
  "url": "http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason",
  "identifier": [
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:oid:2.16.840.1.113883.4.642.40.44.48.19"
    }
  ],
  "version": "1.0.0-ballot3",
  "name": "ICHM11AmendmentReason",
  "title": "ICH M11 Reason for Amendment Value Set",
  "status": "active",
  "experimental": false,
  "date": "2026-09-30T18:49:51+00:00",
  "publisher": "HL7 International / Clinical Decision Support",
  "contact": [
    {
      "name": "HL7 International / Clinical Decision Support",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/dss"
        }
      ]
    }
  ],
  "description": "Terminology associated with the reason for amendment value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217276 drawn from the NCI Thesaurus and represented here in FHIR format. This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-study-amendment-reason-vs.html.",
  "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. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license.\nCDISC 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)\nThe NCI Thesaurus is released under the CC BY 4.0 license\nFurther details at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-reason-vs.html",
  "compose": {
    "include": [
      {
        "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept": [
          {
            "code": "C218497",
            "display": "Change in Standard Of Care Amendment Reason"
          },
          {
            "code": "C218496",
            "display": "Change in Strategy Amendment Reason"
          },
          {
            "code": "C218495",
            "display": "IMP Addition Amendment Reason"
          },
          {
            "code": "C218501",
            "display": "Inconsistency and/or Error in the Protocol Amendment Reason"
          },
          {
            "code": "C218499",
            "display": "Investigator/Site Feedback Amendment Reason"
          },
          {
            "code": "C218492",
            "display": "IRB/IEC Feedback Amendment Reason"
          },
          {
            "code": "C218494",
            "display": "Manufacturing Change Amendment Reason"
          },
          {
            "code": "C218498",
            "display": "New Data Available (Other Than Safety Data) Amendment Reason"
          },
          {
            "code": "C218491",
            "display": "New Regulatory Guidance Amendment Reason"
          },
          {
            "code": "C218493",
            "display": "New Safety Information Available Amendment Reason"
          },
          {
            "code": "C48660",
            "display": "Not Applicable"
          },
          {
            "code": "C17649",
            "display": "Other"
          },
          {
            "code": "C218502",
            "display": "Protocol Design Error Amendment Reason"
          },
          {
            "code": "C218500",
            "display": "Recruitment Difficulty Amendment Reason"
          },
          {
            "code": "C218490",
            "display": "Regulatory Agency Request to Amend Amendment Reason"
          }
        ]
      }
    ]
  }
}