Which best describes the responsibilities for adverse event reporting?

The responsibilities for adverse event reporting are primarily the responsibility of the sponsor. This is grounded in the principles set forth by regulatory authorities and the ICH E6 guidelines, which outline the obligations of sponsors to ensure the safety and welfare of trial participants. The sponsor is responsible for the overall conduct of the clinical trial, including monitoring and reporting any adverse events that may arise during the study. This includes the need to evaluate and report any adverse events to regulatory bodies as required, ensuring that participant safety is prioritized throughout the trial.

In addition, the sponsor is responsible for maintaining oversight of both the clinical trial process and the data collected, which includes adequately training staff to recognize and report adverse events. This responsibility extends beyond just during the active trial phase; they must continuously monitor for adverse events even if no incidents have been reported initially. This diligence helps in identifying any potential risks associated with the investigational product, thus contributing to public safety and informed decision-making.

The other options do not accurately reflect the responsibilities outlined in ICH E6. For instance, stating that adverse event reporting is handled solely by clinical research organizations disregards the sponsor's ultimate accountability. Similarly, claiming that reporting is only required after trial completion contradicts the need for ongoing monitoring during the trial. Lastly