<status value="active"/> <experimental value="false"/> <date value="2026-04-02T08:57:07+00:00"/> <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 whether or not a protocol has been amended. This is ICH M11 Value Set C217274 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> <compose> <include> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <concept> <code value="C218486"/> <display value="First Protocol Amendment"/> </concept> <concept> <code value="C218485"/> <display value="Protocol Not Amended"/> </concept> <concept> <code value="C218488"/> <display value="Protocol Previously Amended See Summary of Changes Before the Table of Contents"/> </concept> <concept> <code value="C218487"/> <display value="Protocol Previously Amended, Details Presented"/> </concept> </include> </compose> </ValueSet>

Generated Narrative: ValueSet m11-amendment-details-statement-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
C218486	First Protocol Amendment	This is the first protocol amendment.
C218485	Protocol Not Amended	This protocol has not been amended.
C218488	Protocol Previously Amended See Summary of Changes Before the Table of Contents	This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent.
C218487	Protocol Previously Amended, Details Presented	This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).