Generated Narrative: ValueSet ich-m11-amendment-details-statement

This value set expansion contains 4 concepts.

SystemCodeDisplay
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218485Protocol Not Amended
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218486First Protocol Amendment
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218487Protocol Previously Amended, Details Presented
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218488Protocol Previously Amended See Summary of Changes Before the Table of Contents
 <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 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. This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-details-statement-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-details-statement-vs.html"/> <compose> <include> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <concept> <code value="C218485"/> <display value="Protocol Not Amended"/> </concept> <concept> <code value="C218486"/> <display value="First Protocol Amendment"/> </concept> <concept> <code value="C218487"/> <display value="Protocol Previously Amended, Details Presented"/> </concept> <concept> <code value="C218488"/> <display value="Protocol Previously Amended See Summary of Changes Before the Table of Contents"/> </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="C218485"/> <display value="Protocol Not Amended"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218486"/> <display value="First Protocol Amendment"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218487"/> <display value="Protocol Previously Amended, Details Presented"/> </contains> <contains> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218488"/> <display value="Protocol Previously Amended See Summary of Changes Before the Table of Contents"/> </contains> </expansion> </ValueSet>