Generated Narrative: ValueSet ich-m11-amendment-reason

This value set expansion contains 15 concepts.

SystemCodeDisplay
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
 <status value="active"/> <experimental value="false"/> <date value="2026-10-02T12:47:35+00:00"/> <publisher value="HL7 International / Clinical Decision Support"/> <contact> <name value="HL7 International / Clinical Decision Support"/> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/dss"/> </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. This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-study-amendment-reason-vs.html."/> <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 Further details at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-reason-vs.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> <expansion> <identifier value="urn:uuid:example-expansion-id"/> <timestamp value="2026-10-02T00:00:00Z"/> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218497"/> <display value="Change in Standard Of Care Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218496"/> <display value="Change in Strategy Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218495"/> <display value="IMP Addition Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218501"/> <display value="Inconsistency and/or Error in the Protocol Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218499"/> <display value="Investigator/Site Feedback Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218492"/> <display value="IRB/IEC Feedback Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218494"/> <display value="Manufacturing Change Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218498"/> <display value="New Data Available (Other Than Safety Data) Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218491"/> <display value="New Regulatory Guidance Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218493"/> <display value="New Safety Information Available Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C48660"/> <display value="Not Applicable"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C17649"/> <display value="Other"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218502"/> <display value="Protocol Design Error Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218500"/> <display value="Recruitment Difficulty Amendment Reason"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218490"/> <display value="Regulatory Agency Request to Amend Amendment Reason"/> </contains> </expansion> </ValueSet>