Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

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 ...

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-blindedRoles-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-blindedRoles-vs</b></p><a name=\"m11-blindedRoles-vs\"> </a><a name=\"hcm11-blindedRoles-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-C142710\">C142710</a></td><td>Participant</td><td>Any individiual that has a role in a study, including study personnel and study subjects.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C17445\">C17445</a></td><td>Care Provider</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-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-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-C70793\">C70793</a></td><td>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-C48660\">C48660</a></td><td>Not Applicable</td><td>Determination of a value is not relevant in the current context.</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-blindedRoles-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs>
  ] ; # 
  fhir:version [ fhir:v "1.0.0-ballot2"] ; # 
  fhir:name [ fhir:v "M11BlindedRolesVS"] ; # 
  fhir:title [ fhir:v "ICH M11 ..."] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-06-04T16:52:10+00:00"^^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 ... 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."] ; # 
  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 "C142710" ] ;
fhir:display [ fhir:v "Participant" ]       ] [
fhir:code [ fhir:v "C17445" ] ;
fhir:display [ fhir:v "Care Provider" ]       ] [
fhir:code [ fhir:v "C25936" ] ;
fhir:display [ fhir:v "Investigator" ]       ] [
fhir:code [ fhir:v "C207599" ] ;
fhir:display [ fhir:v "Outcomes Assessor" ]       ] [
fhir:code [ fhir:v "C70793" ] ;
fhir:display [ fhir:v "Sponsor" ]       ] [
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ]       ] )     ] )
  ] . #