Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : UDP Identifier Type Value Set

Page standards status: Trial-use | Maturity Level: 1

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    {
      "resourceType" : "ValueSet",
      "id" : "udp-identifier-type-vs",
      "language" : "en",
      "text" : {
        "status" : "extensions",
        "div" : "<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>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
          "valueInteger" : 1
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
          "valueCode" : "brr"
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
          "valueCode" : "trial-use",
          "_valueCode" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
              }
            ]
          }
        }
      ],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs",
      "version" : "1.0.0-ballot2",
      "name" : "UDPIdentifierType_VS",
      "title" : "UDP Identifier Type Value Set",
      "status" : "active",
      "experimental" : false,
      "date" : "2026-04-09T17:15:23+10:00",
      "publisher" : "HL7 International / Biomedical Research and Regulation",
      "contact" : [
        {
          "name" : "HL7 International / Biomedical Research and Regulation",
          "telecom" : [
            {
              "system" : "url",
              "value" : "http://www.hl7.org/Special/committees/rcrim"
            },
            {
              "system" : "email",
              "value" : "UDP@HL7Vulcan.org"
            }
          ]
        }
      ],
      "description" : "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.",
      "jurisdiction" : [
        {
          "coding" : [
            {
              "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
              "code" : "001",
              "display" : "World"
            }
          ]
        }
      ],
      "copyright" : "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)",
      "compose" : {
        "include" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "concept" : [
              {
                "code" : "C132351",
                "display" : "Sponsor Protocol Identifier"
              },
              {
                "code" : "C218672",
                "display" : "Original Protocol Indicator"
              },
              {
                "code" : "C218477",
                "display" : "Amendment Identifier"
              },
              {
                "code" : "C218684",
                "display" : "EU Clinical Trial Register Number"
              },
              {
                "code" : "C218685",
                "display" : "US FDA Investigational New Drug Application Number"
              },
              {
                "code" : "C218686",
                "display" : "US FDA Investigational Device Exemption Application Number"
              },
              {
                "code" : "C218687",
                "display" : "Japan Registry for Clinical Trials Number"
              },
              {
                "code" : "C172240",
                "display" : "Clinicaltrials.gov Identifier"
              },
              {
                "code" : "C218688",
                "display" : "NMPA IND Number"
              },
              {
                "code" : "C218689",
                "display" : "WHO/UTN Number"
              },
              {
                "code" : "C218690",
                "display" : "Other Regulatory or Clinical Trial Identifier"
              }
            ]
          }
        ]
      }
    }