ICH ICH Enumeration: ShortName=Control Type Response Terminology

M2 ESTRI Code List

ShortName = Control Type Response Terminology
LongName = Control Type Response Terminology
Version = 1.0
CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.4
CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.4.1
Agency
ShortName = M11
LongName = Clinical Trial protocols
Identifier = C217279
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"
C49649 Active Comparator A type of control, which has a demonstrated effect, administered as a comparator to participants in a clinical trial. y
C218505 Different Dose or Regimen A type of control that comprises a different dose or dosage regimen in comparison to the investigational intervention dose or dosage regimen. y
C120841 Dose Response A type of control using different doses or regimens of the same treatment across the treatment arms. y
C218506 External The use of external control data as a control arm for those studies where ethical concerns and/or underserved disease indications may make it difficult to enroll participants. y
C28280 No Control A clinical study that lacks a comparison (i.e., a control) group. y
C49648 Placebo An inactive, identical-appearing drug or treatment that does not contain the test product. y
C184727 Sham Procedure A type of negative control in which a procedure is performed that mimics the procedure under study but does not include investigational processes or components. 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