{
  "description": "Codes drawn from NCI Thesaurus to represent the reasons a study was amended.",
  "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"
      } ]
    } ]
  },
  "_filename": "ValueSet-m11-study-amendment-reason-vs.json",
  "package_name": "hl7.fhir.uv.pharmaceutical",
  "date": "2025-08-01T12:18:30+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "jurisdiction": [ {
    "coding": [ {
      "code": "001",
      "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "display": "World"
    } ]
  } ],
  "name": "M11StudyAmendmentReasonVS",
  "type": null,
  "experimental": "false",
  "resourceType": "ValueSet",
  "title": "Study Amendment Reason Value Set",
  "package_version": "research-protocol-1.0.0-ballot",
  "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"
      } ]
    }
  } ],
  "status": "draft",
  "id": "4b441680-4655-45b2-b046-31251e88cd7e",
  "kind": null,
  "url": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs",
  "version": "1.0.0-ballot",
  "contact": [ {
    "name": "HL7 International / Biomedical Research and Regulation",
    "telecom": [ {
      "value": "http://www.hl7.org/Special/committees/rcrim",
      "system": "url"
    }, {
      "value": "UDP@HL7Vulcan.org",
      "system": "email"
    } ]
  } ]
}