Statistical Analysis Plans (SAP)

The SAP is a detailed protocol that presents the study aims, definitions of outcomes, statistical hypotheses, methods of analysis and templates for presentation/summarization of results. The choice of the analytic methods depends on the statistical hypothesis (superiority, non-inferiority, equivalence), the type of outcome (continuous, discrete, categorical, censored), the structure of the data (e.g. repeated measures, clustering), elements of the design (e.g. crossover, factorial, stratification, matching) and the presence of missing data.