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

: UDP Study Title Type Value Set

Page standards status: Trial-use Maturity Level: 2

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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 "udp-study-title-type-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 udp-study-title-type-vs</b></p><a name=\"udp-study-title-type-vs\"> </a><a name=\"hcudp-study-title-type-vs\"> </a><p>This value set includes codes based on the following rules:</p><ul><li>Import all the codes that are contained in <a href=\"http://terminology.hl7.org/7.1.0/ValueSet-title-type.html\">Title Type</a></li><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-C207615\">C207615</a></td><td>Brief Study Title</td><td>The short descriptive name for the study.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C207646\">C207646</a></td><td>Study Acronym</td><td>The non-unique initials or abbreviated name used for identification of the study.</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 2     ]
  ] [
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/udp-study-title-type-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs>
  ] ; # 
  fhir:version [ fhir:v "1.0.0-ballot2"] ; # 
  fhir:name [ fhir:v "UDPStudyTitleTypeVS"] ; # 
  fhir:title [ fhir:v "UDP Study Title Type Value Set"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-04-08T21:09:32+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 "These codes represent the types of title or name a study can have \nThis is a UDP specific value set using NCIT codes to extend an HL7 value set.\n\nThese are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute \nrather than being a classifier for a more general attribute.  FHIR structures are designed to work with a repeating\nattribute classified by an approriate terminology. This value set enables that.\nNote that the NCI Thesaurus holds separate codes for protocol name (C132300) that are separate from study title (C49802)"] ; # 
  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:valueSet [
fhir:v "http://terminology.hl7.org/ValueSet/title-type"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/ValueSet/title-type>       ] )     ] [
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 "C207615" ] ;
fhir:display [ fhir:v "Brief Study Title" ]       ] [
fhir:code [ fhir:v "C207646" ] ;
fhir:display [ fhir:v "Study Acronym" ]       ] )     ] )
  ] . #