Investigational Adverse Experience Reporting

Abstract

This discussion centers on the adverse experience reporting techniques and governmental requirements for investigational products (Phases I-III). The adverse experience reporting rate for investigational products has steadily increased over the past six years. To meet this increased reporting rate, the computer systems at Merck have become highly sophisticated. The specific governmental AE reporting requirements for investigational products of North America and Europe are discussed. The two types of AE reporting to governmental agencies currently consist of individual patient reports and safety update reports. It is the author's opinion that European countries are best informed by safety update reports rather than individual patient reporting.