Do I need to report deaths that are expected outcomes on the adverse event report form?
The Saint Louis University’s Guidelines for Reporting SAE’s state: A serious adverse event is reportable if it occurs between the times of inclusion into the protocol (i.e., after signing informed consent) and continues for the duration and following 30 days of the active intervention phase of the protocol. However, the guidelines also state: If the SAE occurs 30 days after the active intervention has stopped, a report may be necessary if there are more stringent reporting requirements set forth in the protocol or mandated by the sponsor. Therefore, while death is an expected outcome for some study participants, an adverse event report must be submitted to the IRB if the death occurs up to 30 days from the last time the individual received the intervention. You must report it to the IRB within 3 calendar days. Any delay in reporting must be explained. In most cases, unless more stringent reporting requirements apply, you would not need to report deaths that occurred beyond the 30-day t
