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 Scope Enrollment Description Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-02 Maturity Level: 0 Computable Name: M11AmendmentScopeEnrollmentVS

Terminology associated with the amendment scope enrollment description value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217275 drawn from the NCI Thesaurus and represented here in FHIR format.

References

Logical Definition (CLD)

 

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  C218489By CohortCovering or affecting a cohort of individuals.
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  C41065LocallyTo a restricted area (of the body).

Description of the above table(s).