Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 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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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:ValueSet ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "m11-blinded-roles-vs"] ; #
      fhir:language [ fhir:v "en"] ; #
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div [ fhir:v "<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 ?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>"^^rdf:XMLLiteral ]
      ] ; #
      fhir:extension ( [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm>     ] ;
    fhir:value [
    a fhir:Integer ;
    fhir:v 0     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg>     ] ;
    fhir:value [
    a fhir:Code ;
    fhir:v "brr"     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status>     ] ;
    fhir:value [
    a fhir:Code ;
    fhir:v "trial-use" ;
          ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom>         ] ;
    fhir:value [
    a fhir:Canonical ;
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol>         ]       ] )     ]
      ] ) ; #
      fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs>
      ] ; #
      fhir:version [ fhir:v "1.0.0-ballot2"] ; #
      fhir:name [ fhir:v "M11BlindedRolesVVS"] ; #
      fhir:title [ fhir:v "ICH M11 Trial Blinding Role Value Set Terminology"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:experimental [ fhir:v false] ; #
      fhir:date [ fhir:v "2026-04-09T17:15:23+10:00"^^xsd:dateTime] ; #
      fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
      fhir:contact ( [
    fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
        ( fhir:telecom [
    fhir:system [ fhir:v "url" ] ;
    fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] [
    fhir:system [ fhir:v "email" ] ;
    fhir:value [ fhir:v "UDP@HL7Vulcan.org" ]     ] )
      ] ) ; #
      fhir:description [ fhir:v "Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217281 drawn from the NCI Thesaurus and represented here in FHIR format."] ; #
      fhir:jurisdiction ( [
        ( fhir:coding [
    fhir:system [
    fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
    fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm>       ] ;
    fhir:code [ fhir:v "001" ] ;
    fhir:display [ fhir:v "World" ]     ] )
      ] ) ; #
      fhir:copyright [ fhir:v "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)"] ; #
      fhir:compose [
        ( fhir:include [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>       ] ;
          ( fhir:concept [
    fhir:code [ fhir:v "C17445" ] ;
    fhir:display [ fhir:v "Caregiver" ]       ] [
    fhir:code [ fhir:v "C70793" ] ;
    fhir:display [ fhir:v "Clinical Study Sponsor" ]       ] [
    fhir:code [ fhir:v "C25936" ] ;
    fhir:display [ fhir:v "Investigator" ]       ] [
    fhir:code [ fhir:v "C48660" ] ;
    fhir:display [ fhir:v "Not Applicable" ]       ] [
    fhir:code [ fhir:v "C207599" ] ;
    fhir:display [ fhir:v "Outcomes Assessor" ]       ] [
    fhir:code [ fhir:v "C142710" ] ;
    fhir:display [ fhir:v "Study Participant" ]       ] )     ] )
      ] . #