m11-amendment-scope-enrollment-vs
type: ValueSet
node role: treeRoot
id:
  v: m11-amendment-scope-enrollment-vs
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: ValueSet m11-amendment-scope-enrollment-vs Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version ?1.0.0-ballot2 Code Display Definition C218489 By Cohort Covering or affecting a cohort of individuals. C68846 Global Covering or affecting the whole of a system. C41065 Locally To a restricted area (of the body).
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 0
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol
        l: hl7.fhir.uv.clinical-study-protocol
url:
  v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs
  l: m11-amendment-scope-enrollment-vs
version:
  v: 1.0.0-ballot2
name:
  v: M11AmendmentScopeEnrollmentVS
title:
  v: ICH M11 Amendment Scope Enrollment Description Value Set Terminology
status:
  v: active
experimental:
  v: false
date:
  v: 2026-04-09T17:15:23+10:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
  name:
    v: HL7 International / Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/rcrim
  telecom:
    system:
      v: email
description:
  v: 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.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
copyright:
  v: 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](licenses.html)
compose:
  include:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      l: Thesaurus.owl
    concept:
      code:
        v: C218489
      display:
        v: By Cohort
    concept:
      code:
        v: C68846
      display:
        v: Global
    concept:
      code:
        v: C41065
      display:
        v: Locally