Clinical Study Protocol
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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

: ICH M11 Trial Blinding Role Value Set Terminology

Page standards status: Trial-use Maturity Level: 0

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="m11-blinded-roles-vs"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet m11-blinded-roles-vs</b></p><a name="m11-blinded-roles-vs"> </a><a name="hcm11-blinded-roles-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><td><b>Definition</b></td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C17445">C17445</a></td><td>Caregiver</td><td>The primary person in charge of the care of a patient, usually a family member or a designated health care professional.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C70793">C70793</a></td><td>Clinical Study Sponsor</td><td>An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C25936">C25936</a></td><td>Investigator</td><td>An individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures.  The investigator monitors the safety of the trial subjects and investigational staff (under whose immediate direction an agent is administered or dispensed to a subject).  The investigator collects and analyses data and study documents, and provides reports in compliance with applicable requirements.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C48660">C48660</a></td><td>Not Applicable</td><td>Determination of a value is not relevant in the current context.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C207599">C207599</a></td><td>Outcomes Assessor</td><td>The individual who evaluates the outcome(s) of interest.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C142710">C142710</a></td><td>Study Participant</td><td>Any individiual that has a role in a study, including study personnel and study subjects.</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="M11BlindedRolesVVS"/>
  <title value="ICH M11 Trial Blinding Role Value Set Terminology"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-08T21:09:32+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
    </telecom>
  </contact>
  <description
               value="Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template.
This is ICH M11 Value Set C217281 drawn from the NCI Thesaurus and represented here in FHIR format."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <copyright
             value="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. 

CDISC 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) 

The NCI Thesaurus is released under the CC BY 4.0 license

For more licensing information and links see: [licenses.html](licenses.html)"/>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C17445"/>
        <display value="Caregiver"/>
      </concept>
      <concept>
        <code value="C70793"/>
        <display value="Clinical Study Sponsor"/>
      </concept>
      <concept>
        <code value="C25936"/>
        <display value="Investigator"/>
      </concept>
      <concept>
        <code value="C48660"/>
        <display value="Not Applicable"/>
      </concept>
      <concept>
        <code value="C207599"/>
        <display value="Outcomes Assessor"/>
      </concept>
      <concept>
        <code value="C142710"/>
        <display value="Study Participant"/>
      </concept>
    </include>
  </compose>
</ValueSet>