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Source1

{
  "resourceType": "ValueSet",
  "id": "limited-m11-section-codes",
  "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/limited-m11-section-codes",
  "identifier": [
    {
      "system": "urn:ietf:rfc:3986",
      "value": "urn:oid:2.16.840.1.113883.4.642.40.44.48.24"
    }
  ],
  "version": "1.0.0-ballot3",
  "name": "LimitedM11SectionCodes",
  "title": "Limited M11 Section Codes 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": "These codes are specified in the M11 technical specification.",
  "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.",
  "compose": {
    "include": [
      {
        "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept": [
          {
            "code": "C217342",
            "display": "ICH M11 Protocol Section 1 PROTOCOL SUMMARY"
          },
          {
            "code": "C217343",
            "display": "ICH M11 Protocol Section 2 INTRODUCTION"
          },
          {
            "code": "C217344",
            "display": "ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"
          },
          {
            "code": "C217345",
            "display": "ICH M11 Protocol Section 4 TRIAL DESIGN"
          },
          {
            "code": "C217346",
            "display": "ICH M11 Protocol Section 5 TRIAL POPULATION"
          },
          {
            "code": "C217347",
            "display": "ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"
          },
          {
            "code": "C217348",
            "display": "ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"
          },
          {
            "code": "C217349",
            "display": "ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"
          },
          {
            "code": "C217350",
            "display": "ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"
          },
          {
            "code": "C217351",
            "display": "ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS"
          },
          {
            "code": "C217352",
            "display": "ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"
          },
          {
            "code": "C217353",
            "display": "ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"
          },
          {
            "code": "C217354",
            "display": "ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"
          },
          {
            "code": "C217355",
            "display": "ICH M11 Protocol Section 14 APPENDIX: REFERENCES"
          },
          {
            "code": "C217356",
            "display": "ICH M11 Protocol Section Title Page"
          },
          {
            "code": "C217357",
            "display": "ICH M11 Protocol Section Amendment Details"
          }
        ]
      }
    ]
  }
}