FHIR IG Statistics: ValueSet/m11-study-amendment-reason-vs

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{
  "resourceType": "ValueSet",
  "id": "m11-study-amendment-reason-vs",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "informative",
      "_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": "0.5.0",
  "name": "M11StudyAmendmentReasonVS",
  "title": "Study Amendment Reaason Value Set",
  "status": "draft",
  "experimental": true,
  "date": "2025-07-22T21:24:53+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"
          }
        ]
      }
    ]
  }
}