Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

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## : ICH M11 Reason for Amendment Value Set Terminology

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    {
      "resourceType" : "ValueSet",
      "id" : "m11-study-amendment-reason-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-reason-vs</b></p><a name=\"m11-study-amendment-reason-vs\"> </a><a name=\"hcm11-study-amendment-reason-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-C218497\">C218497</a></td><td>Change in Standard Of Care Amendment Reason</td><td>A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218496\">C218496</a></td><td>Change in Strategy Amendment Reason</td><td>A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218495\">C218495</a></td><td>IMP Addition Amendment Reason</td><td>The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218501\">C218501</a></td><td>Inconsistency and/or Error in the Protocol Amendment Reason</td><td>An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218499\">C218499</a></td><td>Investigator/Site Feedback Amendment Reason</td><td>Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218492\">C218492</a></td><td>IRB/IEC Feedback Amendment Reason</td><td>Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218494\">C218494</a></td><td>Manufacturing Change Amendment Reason</td><td>A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218498\">C218498</a></td><td>New Data Available (Other Than Safety Data) Amendment Reason</td><td>Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218491\">C218491</a></td><td>New Regulatory Guidance Amendment Reason</td><td>A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218493\">C218493</a></td><td>New Safety Information Available Amendment Reason</td><td>Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.</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><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C17649\">C17649</a></td><td>Other</td><td>Different than the one(s) previously specified or mentioned.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218502\">C218502</a></td><td>Protocol Design Error Amendment Reason</td><td>A protocol design error necessitates a change(s) to, or formal clarification of, a document.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218500\">C218500</a></td><td>Recruitment Difficulty Amendment Reason</td><td>Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218490\">C218490</a></td><td>Regulatory Agency Request to Amend Amendment Reason</td><td>A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.</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-reason-vs",
      "version" : "1.0.0-ballot2",
      "name" : "M11StudyAmendmentReasonVS",
      "title" : "ICH M11 Reason for Amendment 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 reason for amendment value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217276 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" : "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"
              }
            ]
          }
        ]
      }
    }