ICH ICH Enumeration: ShortName=Amendment Details Statement Response Terminology

M2 ESTRI Code List

ShortName = Amendment Details Statement Response Terminology
LongName = Amendment Details Statement Response Terminology
Version = 1.0
CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.1
CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.1.1
Agency
ShortName = M11
LongName = Clinical Trial protocols
Identifier = C217274
code
Id="code"
(required)
Type="string"
english-label
Id="en"
(optional)
Type="string" Lang="en"
M11 Definition
Id="en_def"
(optional)
Type="string" Lang="en"
current flag
Id="cf"
(optional)
Type="string" Lang="en"
C218486 This is the first protocol amendment. This is the first protocol amendment. y
C218487 This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). y
C218488 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. 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. y
C218485 This protocol has not been amended. This protocol has not been amended. y

This file contains a code list co-maintained by ICH M2 ESTRI and CDISC in collaboration with the NCI Enterprise Vocabulary Services (EVS). It is encoded using OASIS genericode. More information on ICH technical standards is available via the M2 ESTRI webpages at www.ich.org.

Change History: v1.0 (November 11 2025)

Report created by ICH_M2_CDISC_Codelist.xsl : [Revision: 1.1 ] : ICH : Harmonisation for Better Health