Pharmaceutical Research Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON
• TTL

: Study Amendment Reason Value Set - JSON Representation

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{
  "resourceType" : "ValueSet",
  "id" : "m11-study-amendment-reason-vs",
  "text" : {
    "status" : "generated",
    "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=\"http://terminology.hl7.org/6.5.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C218490</td><td>Regulatory Agency Request To Amend</td></tr><tr><td>C218491</td><td>New Regulatory Guidance</td></tr><tr><td>C218492</td><td>IRB/IEC Feedback</td></tr><tr><td>C218493</td><td>New Safety Information Available</td></tr><tr><td>C218494</td><td>Manufacturing Change</td></tr><tr><td>C218495</td><td>IMP Addition</td></tr><tr><td>C218496</td><td>Change In Strategy</td></tr><tr><td>C218497</td><td>Change In Standard Of Care</td></tr><tr><td>C218498</td><td>New Data Available (Other Than Safety Data)</td></tr><tr><td>C218499</td><td>Investigator/Site Feedback</td></tr><tr><td>C218500</td><td>Recruitment Difficulty</td></tr><tr><td>C218501</td><td>Inconsistency And/Or Error In The Protocol</td></tr><tr><td>C218502</td><td>Protocol Design Error</td></tr><tr><td>C17649</td><td>Other</td></tr><tr><td>C48660</td><td>Not Applicable</td></tr></table></li></ul></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger" : 2
    },
    {
      "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/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"
          }
        ]
      }
    }
  ],
  "url" : "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs",
  "version" : "1.0.0-ballot",
  "name" : "M11StudyAmendmentReasonVS",
  "title" : "Study Amendment Reason Value Set",
  "status" : "draft",
  "experimental" : false,
  "date" : "2025-07-31T20:39:04+00:00",
  "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" : "Codes drawn from NCI Thesaurus to represent the reasons a study was amended.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept" : [
          {
            "code" : "C218490",
            "display" : "Regulatory Agency Request To Amend"
          },
          {
            "code" : "C218491",
            "display" : "New Regulatory Guidance"
          },
          {
            "code" : "C218492",
            "display" : "IRB/IEC Feedback"
          },
          {
            "code" : "C218493",
            "display" : "New Safety Information Available"
          },
          {
            "code" : "C218494",
            "display" : "Manufacturing Change"
          },
          {
            "code" : "C218495",
            "display" : "IMP Addition"
          },
          {
            "code" : "C218496",
            "display" : "Change In Strategy"
          },
          {
            "code" : "C218497",
            "display" : "Change In Standard Of Care"
          },
          {
            "code" : "C218498",
            "display" : "New Data Available (Other Than Safety Data)"
          },
          {
            "code" : "C218499",
            "display" : "Investigator/Site Feedback"
          },
          {
            "code" : "C218500",
            "display" : "Recruitment Difficulty"
          },
          {
            "code" : "C218501",
            "display" : "Inconsistency And/Or Error In The Protocol"
          },
          {
            "code" : "C218502",
            "display" : "Protocol Design Error"
          },
          {
            "code" : "C17649",
            "display" : "Other"
          },
          {
            "code" : "C48660",
            "display" : "Not Applicable"
          }
        ]
      }
    ]
  }
}