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

## ValueSet: UDP Identifier Type Value Set

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 1 | Computable Name: UDPIdentifierType_VS
Copyright/Legal: 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

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.

References

- M11 Research Study Profile

### Logical Definition (CLD)

- Include these codes as defined in `http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` version 📦1.0.0-ballot2

  Code | Display | Definition
  C132351 | Sponsor Protocol Identifier | A unique code, which is assigned by the sponsor, that identifies a specific protocol.
  C218672 | Original Protocol Indicator | An indication as to whether the protocol document reflects the original version of the protocol.
  C218477 | Amendment Identifier | A sequence of characters used to uniquely identify a protocol amendment.
  C218684 | EU Clinical Trial Register Number | A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency.
  C218685 | US FDA Investigational New Drug Application Number | 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.
  C218686 | US FDA Investigational Device Exemption Application Number | 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.
  C218687 | Japan Registry for Clinical Trials Number | 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.
  C172240 | Clinicaltrials.gov Identifier | The unique alphanumeric identifier for a trial as assigned by the Clinicaltrials.gov Protocol Registration and Results System (PRS).
  C218688 | NMPA IND Number | 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).
  C218689 | WHO/UTN Number | 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).
  C218690 | Other Regulatory or Clinical Trial Identifier | 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.

### Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 11 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C132351 | Sponsor Protocol Identifier | A unique code, which is assigned by the sponsor, that identifies a specific protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218672 | Original Protocol Indicator | An indication as to whether the protocol document reflects the original version of the protocol. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218477 | Amendment Identifier | A sequence of characters used to uniquely identify a protocol amendment. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218684 | EU Clinical Trial Register Number | A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218685 | US FDA Investigational New Drug Application Number | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218686 | US FDA Investigational Device Exemption Application Number | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218687 | Japan Registry for Clinical Trials Number | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C172240 | Clinicaltrials.gov Identifier | The unique alphanumeric identifier for a trial as assigned by the Clinicaltrials.gov Protocol Registration and Results System (PRS). |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218688 | NMPA IND Number | 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). |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218689 | WHO/UTN Number | 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). |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C218690 | Other Regulatory or Clinical Trial Identifier | 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. |  |

Description of the above table(s).