Preferred Label : Sample Size Calculation;
NCIt related terms : SSC; Sample Size Determination;
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]; ICH: 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.;
Codes from synonyms : ICH M11-Section 10;
Origin ID : C115467;
UMLS CUI : C3897657;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
