Clinical Study Protocol
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Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

ValueSet: ICH M11 Amendment Details Statement Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-08 Maturity Level: 0 Computable Name: M11AmendmentDetailsStatementVS

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

For more licensing information and links see: licenses.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.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2
    CodeDisplayDefinition
    C218486First Protocol AmendmentThis is the first protocol amendment.
    C218485Protocol Not AmendedThis protocol has not been amended.
    C218488Protocol Previously Amended See Summary of Changes Before the Table of ContentsThis 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.
    C218487Protocol Previously Amended, Details PresentedThis protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).

 

Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 4 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218486First Protocol AmendmentThis is the first protocol amendment.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218485Protocol Not AmendedThis protocol has not been amended.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218488Protocol Previously Amended See Summary of Changes Before the Table of ContentsThis 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.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C218487Protocol Previously Amended, Details PresentedThis protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).

Description of the above table(s).