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

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
Standards status: Trial-use Active as of 2026-04-08 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

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2
    CodeDisplayDefinition
    C132351Sponsor Protocol IdentifierA unique code, which is assigned by the sponsor, that identifies a specific protocol.
    C218672Original Protocol IndicatorAn indication as to whether the protocol document reflects the original version of the protocol.
    C218477Amendment IdentifierA sequence of characters used to uniquely identify a protocol amendment.
    C218684EU Clinical Trial Register NumberA sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency.
    C218685US FDA Investigational New Drug Application NumberA 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.
    C218686US FDA Investigational Device Exemption Application NumberA 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.
    C218687Japan Registry for Clinical Trials NumberA 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.
    C172240Clinicaltrials.gov IdentifierThe unique alphanumeric identifier for a trial as assigned by the Clinicaltrials.gov Protocol Registration and Results System (PRS).
    C218688NMPA IND NumberA 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).
    C218689WHO/UTN NumberA sequence of characters used to identify a clinical trial, as assigned by the World Health organization's International Clinical Trial's Registry Platform (ICTRP).
    C218690Other Regulatory or Clinical Trial IdentifierA 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

SystemCodeDisplay (en)DefinitionJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C132351Sponsor Protocol IdentifierA unique code, which is assigned by the sponsor, that identifies a specific protocol.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218672Original Protocol IndicatorAn indication as to whether the protocol document reflects the original version of the protocol.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218477Amendment IdentifierA sequence of characters used to uniquely identify a protocol amendment.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218684EU Clinical Trial Register NumberA 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  C218685US FDA Investigational New Drug Application NumberA 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  C218686US FDA Investigational Device Exemption Application NumberA 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  C218687Japan Registry for Clinical Trials NumberA 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  C172240Clinicaltrials.gov IdentifierThe 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  C218688NMPA IND NumberA 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  C218689WHO/UTN NumberA 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  C218690Other Regulatory or Clinical Trial IdentifierA 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).