Current Edition

Patient Safety Narratives in Clinical Studies

An important part of clinical study reporting, safety narratives should be prepared for all phases of clinical studies, whether conducted in healthy volunteers or in patients with the disease/condition under study. In her paper, Yvonne Moores of Quanticate describes current regulatory requirements with regard to safety narratives and a proposed process for their development and review, and examines ways to simplify the reporting process, thereby reducing the burden of time and cost.