Clinical Study Protocol, 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-ballot2 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

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: ICH M11 ...

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{
  "resourceType" : "ValueSet",
  "id" : "m11-trialBlindSchema-vs",
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet m11-trialBlindSchema-vs</b></p><a name=\"m11-trialBlindSchema-vs\"> </a><a name=\"hcm11-trialBlindSchema-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></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C15228\">C15228</a></td><td>Double Blind</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C187674\">C187674</a></td><td>Observer Blind</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C49659\">C49659</a></td><td>Open Label</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C28233\">C28233</a></td><td>Single Blind</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-trialBlindSchema-vs",
  "version" : "1.0.0-ballot2",
  "name" : "M11TrialBlindSchemaVS",
  "title" : "ICH M11 ...",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-06-04T16:52:10+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" : "Terminology associated with the ... value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set ... 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" : "C15228",
            "display" : "Double Blind"
          },
          {
            "code" : "C187674",
            "display" : "Observer Blind"
          },
          {
            "code" : "C49659",
            "display" : "Open Label"
          },
          {
            "code" : "C28233",
            "display" : "Single Blind"
          }
        ]
      }
    ]
  }
}