Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

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 Scope Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-08 Maturity Level: 0 Computable Name: M11AmendmentScopeVS

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 the amendment scope value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format.

The M11 guidance to "leave blank" if not applicable has to be replaced by an explicit "Not Applicable"

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
    C68846GlobalCovering or affecting the whole of a system.
    C217026Not GlobalCovering or affecting only a portion of the entire system.
    C48660Not ApplicableDetermination of a value is not relevant in the current context.

 

Expansion

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

This value set contains 3 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C68846GlobalCovering or affecting the whole of a system.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C217026Not GlobalCovering or affecting only a portion of the entire system.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C48660Not ApplicableDetermination of a value is not relevant in the current context.

Description of the above table(s).