Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

ValueSet: ICH M11 Trial Phase Value Set

Official URL: http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-trial-phase Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: ICHM11TrialPhase
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.22

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 Further details at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-phase-vs.html

Terminology associated with the trial phase value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217045 drawn from the NCI Thesaurus and represented here in FHIR format. This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-phase-vs.html.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version Not Stated (use latest from terminology server)
    CodeDisplay
    C54721Early Phase 1 Trial
    C15600Phase I Trial
    C15693Phase I/II Trial
    C198366Phase I/II/III Trial
    C198367Phase I/III Trial
    C15601Phase II Trial
    C15694Phase II/III Trial
    C217024Phase II/III/IV Trial
    C15602Phase III Trial
    C217025Phase III/IV Trial
    C15603Phase IV Trial

 

Expansion

This value set expansion contains 11 concepts.

SystemCodeDisplayJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C54721Early Phase 1 Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C15600Phase I Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C15693Phase I/II Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C198366Phase I/II/III Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C198367Phase I/III Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C15601Phase II Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C15694Phase II/III Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217024Phase II/III/IV Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C15602Phase III Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217025Phase III/IV Trial
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C15603Phase IV Trial

Description of the above table(s).