ShortName = ICH M11 Section 10 Terminology LongName = ICH M11 Section 10 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.10 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.10.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217351
| 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" |
|---|---|---|---|
| C218802 | Analyses of Demographics and Other Baseline Variables | A description of analyses relevant to variables at baseline, for example demographics, related to the trial. | y |
| C218807 | Analyses Associated with the Exploratory Objective(s) | A description of the statistical model, hypothesis, and methods of analyses for each exploratory objective within the trial. | y |
| C218801 | Analysis Sets | A description of the set of participants whose data are to be included in the analyses. | y |
| C164387 | General Considerations | Careful thought or deliberation related to the planned conduct of statistical analyses within the context of the trial. | y |
| C218803 | Handling of Data in Relation to Primary Estimand(s) | A description of how data will be handled for the statistical analysis in line with the primary estimand. | y |
| C218805 | Handling of Data in Relation to Secondary Estimand(s) | A description of how data will be handled for the statistical analysis in line with the secondary estimand. | y |
| C218804 | Handling of Missing Data in Relation to Primary Estimand(s) | A description of how missing data associated with the primary estimand will be handled, including the rationale for the approach. | y |
| C218806 | Handling of Missing Data in Relation to Secondary Estimand(s) | A description of how missing data associated with the secondary estimand will be handled, including the rationale for the approach. | y |
| C142582 | Interim Analyses | A description of any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. | y |
| C218810 | Multiplicity Adjustments | A description of the statistical adjustments needed to limit the probability of false positive findings in trials where there are multiple simultaneous hypotheses. | y |
| C218809 | Other Analyses | A description of the analyses that are different than the one(s) previously specified or mentioned. | y |
| C218808 | Safety Analyses | A description of the analyses of relevant safety variables, including adverse events of special interest. | y |
| C115467 | Sample Size Determination | A statistical calculation to determine the number of participants required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. If the sample size is determined on some other basis, then this should be made clear and justified. | y |
| C218480 | Sensitivity Analysis | A description of the series of analyses conducted to explore the robustness of inferences from the main estimator to deviations from its underlying modeling assumptions and limitations in the data. | y |
| C218482 | Statistical Analysis Method | A description of the statistical model, hypothesis, and methods of analyses for each objective within the trial. | y |
| C218481 | Supplementary Analysis | A description of the analyses that are conducted in addition to the main and sensitivity analysis with the intent to provide additional insights into the understanding of the treatment effect. | 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