ShortName = ICH M11 Section 3 Terminology LongName = ICH M11 Section 3 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.3 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.3.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217344
| 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" |
|---|---|---|---|
| C188856 | Description of Intercurrent Event | A description of the intercurrent event. | y |
| C25212 | Endpoint | The variable to be obtained for each patient that is required to address the clinical question. The specification of the variable might include whether the patient experiences an intercurrent event. | y |
| C163559 | Exploratory Objective | The exploratory reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. | y |
| C188857 | Intercurrent Event Strategy | A description of the planned strategy to address intercurrent events. | y |
| C70833 | Population | The population of patients targeted by the clinical question. This will be represented by the entire trial population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. | y |
| C188853 | Population-level Summary | Population level summary for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions. | y |
| C85826 | Primary Objective | The principle reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. | y |
| C85827 | Secondary Objective | The secondary reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. | y |
| C49236 | Treatment | The treatment condition of interest and, as appropriate, the alternative treatment condition to which comparison will be made (referred to as "treatment" through the remainder of this document). These might be individual interventions, combinations of interventions administered concurrently, e.g. as add-on to standard of care, or might consist of an overall regimen involving a complex sequence of interventions. | 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