Review of Statistical Analysis Plans (Summary locked)

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ABSTRACT

A statistical analysis plan (SAP) describes the planned analysis for a clinical trial. SAPs must be carefully reviewed by statistical programmers working on the project for clarity and comprehension in order to construct analysis data sets and prepare planned Tables, Figures, and Listings. SAP review is a challenging task that requires both statistical expertise and abstract thinking skills, and is often times completed in the absence of available trial data. Statistical programmers must also develop critical evaluation and communications skills to prospectively identify issues and seek clarity with statistical colleagues on planned analyses on a trial or a development program. Statistical programmer education and training is highly variable and is derived from multiple disciplines, suggesting that comprehensive training on SAP review is an essential skill to ensure consistency and quality within the project. This Wiki provides training guidance on how a structured comprehensive SAP review and how awareness of statistics can be increased for the statistical programmer, with a resulting quality improvement of the statistical programming work products.