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The Statistical Analysis Plan (SAP) is a detailed roadmap for conducting statistical analyses of the data collected in a clinical study. It provides further details on the statistical methods described in the study protocol. A comprehensive SAP is crucial for ensuring accurate methods and reproducibility of study findings. According to the ICH-E9 guideline, the SAP should be approved before database lock and study unblinding. Deviations introduced before database lock are often included in the SAP, together with the reasons for those deviations. Deviations introduced after database lock are obviously not included in the SAP. Any deviation from the planned analyses needs to be clarified in the study report.
Emtex Statisticians use their extensive experience to develop SAPs that meet regulatory standards and study objectives. Additionally, they can also offer practical guidance to programmers, ensuring consistency and accuracy in statistical outputs. In this regard, the SAP is often accompanied by a set of empty shells of tables, listings, and figures (Mock TLFs) that provide a good understanding of statistical output (in terms of type and format) to be expected.