SAP (Statistical Analysis Plan)

A Statistical Analysis Plan (SAP) is a detailed document that outlines how data from a clinical study will be analyzed to ensure accurate and objective results. It specifies the methods, statistical tests, and procedures to interpret the data collected, helping to prevent bias and ensure consistency. Essentially, the SAP acts as a roadmap for researchers, guiding them on how to evaluate the study data methodically and transparently, which is crucial for assessing the safety and effectiveness of a new treatment or intervention.