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 Amendment Details Statement Value Set

Official URL: http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: ICHM11AmendmentDetailsStatement
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.18

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-details-statement-vs.html

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.

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
    C218485Protocol Not Amended
    C218486First Protocol Amendment
    C218487Protocol Previously Amended, Details Presented
    C218488Protocol Previously Amended See Summary of Changes Before the Table of Contents

 

Expansion

This value set expansion contains 4 concepts.

SystemCodeDisplayJSONXML
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

Description of the above table(s).