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 Identifier Type Value Set

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="udp-identifier-type-vs"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <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 &#x1F4E6;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>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="UDPIdentifierType_VS"/>
  <title value="UDP Identifier Type Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-08T21:09:32+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
    </telecom>
  </contact>
  <description
               value="These codes represent the types of identifier used ina study.
This is a UDP specific value set.
These are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute 
rather than being a classifier for a more general attribute.  FHIR structures are designed to work with a repeating
identifier attribute classified by an approriate terminology. This value set enables that by using NCIT codes to create a FHIR value set."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <copyright
             value="Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. 
The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. 

CDISC publishes semantics for the ICH M11 protocol data elements and valid 
value sets. This terminology set is published and stored in the NCI Thesaurus 
Subset C217023 - ICH M11 Terminology 
(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) 

The NCI Thesaurus is released under the CC BY 4.0 license

For more licensing information and links see: [licenses.html](licenses.html)"/>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C132351"/>
        <display value="Sponsor Protocol Identifier"/>
      </concept>
      <concept>
        <code value="C218672"/>
        <display value="Original Protocol Indicator"/>
      </concept>
      <concept>
        <code value="C218477"/>
        <display value="Amendment Identifier"/>
      </concept>
      <concept>
        <code value="C218684"/>
        <display value="EU Clinical Trial Register Number"/>
      </concept>
      <concept>
        <code value="C218685"/>
        <display value="US FDA Investigational New Drug Application Number"/>
      </concept>
      <concept>
        <code value="C218686"/>
        <display
                 value="US FDA Investigational Device Exemption Application Number"/>
      </concept>
      <concept>
        <code value="C218687"/>
        <display value="Japan Registry for Clinical Trials Number"/>
      </concept>
      <concept>
        <code value="C172240"/>
        <display value="Clinicaltrials.gov Identifier"/>
      </concept>
      <concept>
        <code value="C218688"/>
        <display value="NMPA IND Number"/>
      </concept>
      <concept>
        <code value="C218689"/>
        <display value="WHO/UTN Number"/>
      </concept>
      <concept>
        <code value="C218690"/>
        <display value="Other Regulatory or Clinical Trial Identifier"/>
      </concept>
    </include>
  </compose>
</ValueSet>