" /> Sample Size Calculation - CISMeF





Preferred Label : Sample Size Calculation;

NCIt related terms : SSC;

NCIt definition : The mathematical techniques, assumptions, and data used to calculate a sample size.;

Alternative definition : CDISC-GLOSS: A statistical calculation to determine the number of subjects 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. [After ICH E9, 3.5]; CareLex: A record of the mathematical technique, assumptions and output used to calculate the sample size; can include quality control (QC) and sign off. [Adapted from TMF-RM];

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21/05/2025


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