Statistical Analysis Plan (SAP)

A statistical analysis plan  (SAP) is a detailed document outlining the statistical methodologies, techniques, and procedures that will be used to analyze the trial’s data. It specifies the statistical endpoints, hypotheses to be tested, data handling methods, and the software to be used. The SAP ensures that the analysis is conducted rigorously, transparently, and in accordance with the study’s objectives and design. It is a critical component for regulatory submissions, data interpretation, and the overall success of the clinical trial.