ICH ICH Enumeration: ShortName=ICH M11 Section 7 Terminology

M2 ESTRI Code List

ShortName = ICH M11 Section 7 Terminology
LongName = ICH M11 Section 7 Terminology
Version = 1.0
CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.7
CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.7.1
Agency
ShortName = M11
LongName = Clinical Trial protocols
Identifier = C217348
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"
C218768 Management of Loss to Follow-Up The mitigation strategies to be employed for the loss or lack of continuation of a participant to follow-up, including the frequency by which follow-up occurs. y
C218767 Participant Discontinuation or Withdrawal from Trial The rationale for why the participant either discontinued or withdrew from the trial. y
C218764 Permanent Discontinuation of Trial Intervention The requirements that must be met in order to permanently discontinue the administration of trial intervention. y
C218766 Rechallenge The requirements that must be met in order to reintroduce previously withdrawn or temporarily discontinued medical intervention in the same participant. y
C218765 Temporary Discontinuation of Trial Intervention The requirements that must be met in order to temporarily discontinue the administration of trial intervention. 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