<status value="active"/> <experimental value="false"/> <date value="2026-04-09T17:15:23+10:00"/> <publisher value="HL7 International / Biomedical Research and Regulation"/> <contact> <name value="HL7 International / Biomedical Research and Regulation"/> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim"/> </telecom> <telecom> <system value="email"/> <value value="UDP@HL7Vulcan.org"/> </telecom> </contact> <description value="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."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <copyright value="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](licenses.html)"/> <compose> <include> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <concept> <code value="C218497"/> <display value="Change in Standard Of Care Amendment Reason"/> </concept> <concept> <code value="C218496"/> <display value="Change in Strategy Amendment Reason"/> </concept> <concept> <code value="C218495"/> <display value="IMP Addition Amendment Reason"/> </concept> <concept> <code value="C218501"/> <display value="Inconsistency and/or Error in the Protocol Amendment Reason"/> </concept> <concept> <code value="C218499"/> <display value="Investigator/Site Feedback Amendment Reason"/> </concept> <concept> <code value="C218492"/> <display value="IRB/IEC Feedback Amendment Reason"/> </concept> <concept> <code value="C218494"/> <display value="Manufacturing Change Amendment Reason"/> </concept> <concept> <code value="C218498"/> <display value="New Data Available (Other Than Safety Data) Amendment Reason"/> </concept> <concept> <code value="C218491"/> <display value="New Regulatory Guidance Amendment Reason"/> </concept> <concept> <code value="C218493"/> <display value="New Safety Information Available Amendment Reason"/> </concept> <concept> <code value="C48660"/> <display value="Not Applicable"/> </concept> <concept> <code value="C17649"/> <display value="Other"/> </concept> <concept> <code value="C218502"/> <display value="Protocol Design Error Amendment Reason"/> </concept> <concept> <code value="C218500"/> <display value="Recruitment Difficulty Amendment Reason"/> </concept> <concept> <code value="C218490"/> <display value="Regulatory Agency Request to Amend Amendment Reason"/> </concept> </include> </compose> </ValueSet>

Generated Narrative: ValueSet m11-study-amendment-reason-vs

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

Code	Display	Definition
C218497	Change in Standard Of Care Amendment Reason	A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.
C218496	Change in Strategy Amendment Reason	A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.
C218495	IMP Addition Amendment Reason	The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.
C218501	Inconsistency and/or Error in the Protocol Amendment Reason	An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.
C218499	Investigator/Site Feedback Amendment Reason	Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.
C218492	IRB/IEC Feedback Amendment Reason	Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.
C218494	Manufacturing Change Amendment Reason	A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.
C218498	New Data Available (Other Than Safety Data) Amendment Reason	Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
C218491	New Regulatory Guidance Amendment Reason	A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.
C218493	New Safety Information Available Amendment Reason	Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
C48660	Not Applicable	Determination of a value is not relevant in the current context.
C17649	Other	Different than the one(s) previously specified or mentioned.
C218502	Protocol Design Error Amendment Reason	A protocol design error necessitates a change(s) to, or formal clarification of, a document.
C218500	Recruitment Difficulty Amendment Reason	Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.
C218490	Regulatory Agency Request to Amend Amendment Reason	A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.