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

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ValueSet: ICH M11 Amendment Scope Value Set

Official URL: http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope				Version: 1.0.0-ballot3	Highlight text changes?
Standards status: Trial-use				Maturity Level: 1	Computable Name: ICHM11AmendmentScope
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.48.21
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-scope-vs.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' This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-scope-vs.html.

References

• ResearchStudyM11ProtocolAmendment

Logical Definition (CLD)

 

Expansion

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Description of the above table(s).