Preparing Annual Safety Reports

Sponsors in the USA are required to submit annually to the FDA a summary of safety findings of investigational products. This involves verification of AE tabulations against computer data listings and the preparation of safety tables. The current findings are reviewed and compared with AE data from the past reporting period.

The sponsor's representatives must be able to clarify any outstanding issues regarding safety interpretation and presentation of the data. Since this information is of critical importance to the FDA, the annual report must be written in a clear, concise manner that accurately summarizes and interprets the safety results. The annual report should provide clear, simple graphs, tables, and figures to illustrate and support safety findings. Following the submission of the annual report, safety findings are usually integrated into an updated version of the IB.

To be able to prepare annual reports, the sponsor's representative should know how the reports satisfy FDA requirements and those of other regulatory authorities. The clinical representative should be able to interpret clinical safety and laboratory findings. The ability to understand computer-generated clinical output and the organization and structure of the NDA/BLA safety database is important.

The annual report and NDA/BLA safety update review and approval procedures must be understood as well as the procedures for the preparation of the IB.

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