In clinical trials, several key players, including sponsors, investigators, Contract Research Organizations (CROs), and Institutional Review Boards (IRBs), each have distinct roles and responsibilities. When unexpected adverse events occur during a trial, these events must be reported and addressed promptly. However, given the complexity of these roles, how do you think communication and responsibility should be coordinated when such events arise? Should there be a standardized, predefined process for assigning accountability across the different parties involved, or should this depend on the specific nature of the event? Additionally, how might variations in handling adverse events impact patient trust and the overall perception of clinical trials? What strategies could be employed to ensure transparency and maintain trust when unforeseen issues occur during a trial?
