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

: UDP Identifier Type Value Set

Page standards status: Trial-use Maturity Level: 1

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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-identifier-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-identifier-type-vs</b></p><a name=\"udp-identifier-type-vs\"> </a><a name=\"hcudp-identifier-type-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-C132351\">C132351</a></td><td>Sponsor Protocol Identifier</td><td>A unique code, which is assigned by the sponsor, that identifies a specific protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218672\">C218672</a></td><td>Original Protocol Indicator</td><td>An indication as to whether the protocol document reflects the original version of the protocol.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218477\">C218477</a></td><td>Amendment Identifier</td><td>A sequence of characters used to uniquely identify a protocol amendment.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218684\">C218684</a></td><td>EU Clinical Trial Register Number</td><td>A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218685\">C218685</a></td><td>US FDA Investigational New Drug Application Number</td><td>A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the US Food and Drug Administration.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218686\">C218686</a></td><td>US FDA Investigational Device Exemption Application Number</td><td>A sequence of characters used to identify a clinical trial under an Investigational Device Exemption (IDE) application, as assigned by the US Food and Drug Administration.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218687\">C218687</a></td><td>Japan Registry for Clinical Trials Number</td><td>A sequence of characters used to identify a clinical trial, as assigned by the Japan Registry for Clinical Trials (JRCT) of the Ministry of Health, Labour and Welfare (MHLW) in Japan.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C172240\">C172240</a></td><td>Clinicaltrials.gov Identifier</td><td>The unique alphanumeric identifier for a trial as assigned by the Clinicaltrials.gov Protocol Registration and Results System (PRS).</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218688\">C218688</a></td><td>NMPA IND Number</td><td>A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the Chinese National Medicinal Products Administration (NMPA).</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218689\">C218689</a></td><td>WHO/UTN Number</td><td>A sequence of characters used to identify a clinical trial, as assigned by the World Health organization's International Clinical Trial's Registry Platform (ICTRP).</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218690\">C218690</a></td><td>Other Regulatory or Clinical Trial Identifier</td><td>A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned.</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 1     ]
  ] [
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-identifier-type-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs>
  ] ; # 
  fhir:version [ fhir:v "1.0.0-ballot2"] ; # 
  fhir:name [ fhir:v "UDPIdentifierType_VS"] ; # 
  fhir:title [ fhir:v "UDP Identifier Type Value Set"] ; # 
  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 "These codes represent the types of identifier used ina study.\nThis is a UDP specific value set.\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\nidentifier attribute classified by an approriate terminology. This value set enables that by using NCIT codes to create a FHIR value set."] ; # 
  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 "C132351" ] ;
fhir:display [ fhir:v "Sponsor Protocol Identifier" ]       ] [
fhir:code [ fhir:v "C218672" ] ;
fhir:display [ fhir:v "Original Protocol Indicator" ]       ] [
fhir:code [ fhir:v "C218477" ] ;
fhir:display [ fhir:v "Amendment Identifier" ]       ] [
fhir:code [ fhir:v "C218684" ] ;
fhir:display [ fhir:v "EU Clinical Trial Register Number" ]       ] [
fhir:code [ fhir:v "C218685" ] ;
fhir:display [ fhir:v "US FDA Investigational New Drug Application Number" ]       ] [
fhir:code [ fhir:v "C218686" ] ;
fhir:display [ fhir:v "US FDA Investigational Device Exemption Application Number" ]       ] [
fhir:code [ fhir:v "C218687" ] ;
fhir:display [ fhir:v "Japan Registry for Clinical Trials Number" ]       ] [
fhir:code [ fhir:v "C172240" ] ;
fhir:display [ fhir:v "Clinicaltrials.gov Identifier" ]       ] [
fhir:code [ fhir:v "C218688" ] ;
fhir:display [ fhir:v "NMPA IND Number" ]       ] [
fhir:code [ fhir:v "C218689" ] ;
fhir:display [ fhir:v "WHO/UTN Number" ]       ] [
fhir:code [ fhir:v "C218690" ] ;
fhir:display [ fhir:v "Other Regulatory or Clinical Trial Identifier" ]       ] )     ] )
  ] . #