| Name | Value | Comments |
|---|
compose.inactive | | |
compose.lockedDate | | |
copyright | | 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-details-statement-vs.html | - Added the item '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-details-statement-vs.html'
|
date | 2022-02-10T20:40:00+00:00 | 2026-10-02T12:47:35+00:00 | |
description | Codes that convey the type of label that is provided. | 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. This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-details-statement-vs.html. | |
experimental | false | |
immutable | true | | |
jurisdiction | | |
 jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 | |
name | ResearchStudyClassifiers | ICHM11AmendmentDetailsStatement | |
publisher | HL7 (FHIR Project) | HL7 International / Clinical Decision Support | |
purpose | | |
status | draft | active | |
title | Research Study Classifiers | ICH M11 Amendment Details Statement Value Set | |
url | http://hl7.org/fhir/ValueSet/research-study-classifiers | http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-details-statement | |
version | 6.0.0-ballot3 | 1.0.0-ballot3 | |