ABSTRACT
In 2009, the Safety Planning, Evaluation, and Reporting Team (SPERT) (a team formed in 2006 by the Pharmaceutical Research and Manufacturers of America to recommend a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting) recommended that sponsors create a program safety analysis plan (PSAP) early in product development (Crowe et al., 2009). The PSAP is described as a living document (updated periodically and amended as needed in response to the emerging safety pro-le) that eventually forms the basis for the statistical analysis plan (SAP) for the Summary of Clinical Safety (SCS). The PSAP generally has two main sections: a standard data collection plan and an analytical section. It can be a stand-alone document or can be embedded in a different document.
