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 Amendment Scope Enrollment Description 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-amendment-scope-enrollment-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-amendment-scope-enrollment-vs</b></p><a name=\"m11-amendment-scope-enrollment-vs\"> </a><a name=\"hcm11-amendment-scope-enrollment-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-C218489\">C218489</a></td><td>By Cohort</td><td>Covering or affecting a cohort of individuals.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C68846\">C68846</a></td><td>Global</td><td>Covering or affecting the whole of a system.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C41065\">C41065</a></td><td>Locally</td><td>To a restricted area (of the body).</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-amendment-scope-enrollment-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs>
  ] ; # 
  fhir:version [ fhir:v "1.0.0-ballot2"] ; # 
  fhir:name [ fhir:v "M11AmendmentScopeEnrollmentVS"] ; # 
  fhir:title [ fhir:v "ICH M11 Amendment Scope Enrollment Description Value Set Terminology"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-04-02T08:57:07+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 amendment scope enrollment description value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217275 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: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 "C218489" ] ;
fhir:display [ fhir:v "By Cohort" ]       ] [
fhir:code [ fhir:v "C68846" ] ;
fhir:display [ fhir:v "Global" ]       ] [
fhir:code [ fhir:v "C41065" ] ;
fhir:display [ fhir:v "Locally" ]       ] )     ] )
  ] . #