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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<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="2026-04-02T08:57:07+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>
  <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>