m11-amendment-details-statement-vs
type: ValueSet
node role: treeRoot
id:
  v: m11-amendment-details-statement-vs
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: ValueSet m11-amendment-details-statement-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 C218486 First Protocol Amendment This is the first protocol amendment. C218485 Protocol Not Amended This protocol has not been amended. C218488 Protocol Previously Amended See Summary of Changes Before the Table of Contents This 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. C218487 Protocol Previously Amended, Details Presented This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).
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-details-statement-vs
  l: m11-amendment-details-statement-vs
version:
  v: 1.0.0-ballot2
name:
  v: M11AmendmentDetailsStatementVS
title:
  v: ICH M11 Amendment Details Statement 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 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.
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: C218486
      display:
        v: First Protocol Amendment
    concept:
      code:
        v: C218485
      display:
        v: Protocol Not Amended
    concept:
      code:
        v: C218488
      display:
        v: Protocol Previously Amended See Summary of Changes Before the Table of Contents
    concept:
      code:
        v: C218487
      display:
        v: Protocol Previously Amended, Details Presented