DIA 2021 Global Annual Meeting

Safety reporting requirements place heavy burden on sites. Sponsors struggle to keep up with changing global regulations and end up overdistributing, sending duplicate or unnecessary reports. A review of 9 years of safety reports found 86% of safety letters received by sites were uninformative or unnecessary, and over 50% did not meet FDA expectedness and causality criteria. In this session, we discuss the changes implemented by a sponsor to become more favored in safety reporting by sites.