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 Reason for Amendment Value Set

Official URL: http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: ICHM11AmendmentReason
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.19

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-amendment-reason-vs.html

Terminology associated with the reason for amendment value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217276 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-study-amendment-reason-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
    C218497Change in Standard Of Care Amendment Reason
    C218496Change in Strategy Amendment Reason
    C218495IMP Addition Amendment Reason
    C218501Inconsistency and/or Error in the Protocol Amendment Reason
    C218499Investigator/Site Feedback Amendment Reason
    C218492IRB/IEC Feedback Amendment Reason
    C218494Manufacturing Change Amendment Reason
    C218498New Data Available (Other Than Safety Data) Amendment Reason
    C218491New Regulatory Guidance Amendment Reason
    C218493New Safety Information Available Amendment Reason
    C48660Not Applicable
    C17649Other
    C218502Protocol Design Error Amendment Reason
    C218500Recruitment Difficulty Amendment Reason
    C218490Regulatory Agency Request to Amend Amendment Reason

 

Expansion

This value set expansion contains 15 concepts.

SystemCodeDisplayJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218497Change in Standard Of Care Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218496Change in Strategy Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218495IMP Addition Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218501Inconsistency and/or Error in the Protocol Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218499Investigator/Site Feedback Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218492IRB/IEC Feedback Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218494Manufacturing Change Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218498New Data Available (Other Than Safety Data) Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218491New Regulatory Guidance Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218493New Safety Information Available Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C48660Not Applicable
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C17649Other
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218502Protocol Design Error Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218500Recruitment Difficulty Amendment Reason
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218490Regulatory Agency Request to Amend Amendment Reason

Description of the above table(s).