An Introduction to Statistical Analysis Plans (SAPs) [Video]

Learn how a Statistical Analysis Plan, or SAP, defines exactly how clinical trial data are analysed to turn protocol objectives into credible, reproducible results.

In this explainer, we outline what a SAP is, where it fits in the study documentation, and why regulators require it before database lock. You’ll learn how it connects the protocol, estimands, and analysis datasets, guiding every step from raw data to tables, listings, and figures. We explain the structure of a strong SAP, including analysis populations, data standards such as CDISC SDTM and ADaM, general conventions for missing data and outliers, and statistical methods for different endpoint types. We also walk through key operational controls: defining derivations and analysis flags, locking the SAP before data review, version control and change management, and quality checks to ensure consistency and audit readiness.

At Quanticate, our biometrics teams help sponsors design, review, and implement Statistical Analysis Plans that ensure compliance, efficiency, and data integrity across studies. Submit an RFI today.