ABSTRACT: BASED ON THE ASSUMPTION THAT MINOR symptoms may presage serious events, we report four years' experience with a web-based adverse event (AE) tracking system (eAETS) designed to capture AEs of a minor nature that would not meet criteria for ethical review. The eAETS has supported 175 diverse clinical protocols, is user-friendly and navigationally intuitive, and restricts access based on protocol ownership. The user creates an initial risk profile for comparison to subsequent AEs to identify unanticipated patterns. Out of 2,440 AE reports, 1,053 did not match the risk profile. Corrective modification was recommended in 6 (13%) protocols. The eAETS provides a framework for weighing the impact of AEs on subject safety.
Journal of Empirical Research on Human Research Ethics 01/2008; 2(4):81-91. · 1.27 Impact Factor