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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{
  "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" : "2026-04-02T08:57:07+00:00",
  "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"
        }
      ]
    }
  ],
  "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"
          }
        ]
      }
    ]
  }
}