Figure 5 (Best Practices for Adverse Event Reporting to FDA by Registries of Postmarket Products) is a flow chart providing a broad overview of the FDA reporting requirements for adverse events (AEs), and shows how reporting differs according to whether the registry has direct patient interaction and whether it receives sponsorship and/or financial support from a regulated industry. The flow chart is a series of 15 rectangles with arrows indicating numerous points of divergence, and the consequent actions to be taken based on the situation at each point in time. Timelines for reporting are provided. A dotted rectangle explains the particular standards that apply to devices as opposed to drugs. The Note at the bottom of the figure defines the abbreviations used: AD = adverse event; SAE = serious adverse event; FDA = U.S. Food and Drug Administration; PSUR = periodic safety update report.

Figure 5Best Practices for Adverse Event Reporting to FDA by Registries of Postmarket Products

Note: AE = adverse event; SAE = serious adverse event; FDA = U.S. Food and Drug Administration; PSUR = periodic safety update report.

From: Chapter 12, Adverse Event Detection, Processing, and Reporting

Cover of Registries for Evaluating Patient Outcomes: A User's Guide
Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition.
Gliklich RE, Dreyer NA, editors.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.