ICH ICH Enumeration: ShortName=Independent Committee Name Response Terminology

M2 ESTRI Code List

ShortName = Independent Committee Name Response Terminology
LongName = Independent Committee Name Response Terminology
Version = 1.0
CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.5
CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.5.1
Agency
ShortName = M11
LongName = Clinical Trial protocols
Identifier = C217282
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"
C215671 Dose Escalation Committee A type of safety monitoring committee that monitors dose escalation activities in first-in-human trials. y
C78726 Endpoint Adjudication Committee An external committee whose purpose is to evaluate study data and decide whether a study endpoint or other criterion has been met. y
C142578 Independent Data Monitoring Committee A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. y
C41132 None No person or thing, nobody, not any. y
C17649 Other Different than the one(s) previously specified or mentioned. 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