SAE Reporting
Serious adverse event (SAE) reporting
Adverse event is serious and should be reported when the participant’s outcome is associated with death, admission to hospital, prolongation of hospital stays, persistent or significant disability or incapacity, congenital abnormal/birth defect or is otherwise life threatening or important medical event in connection with a clinical trial.
Investigators are expected to present a section of SAE and its report in the proposal. According to the National Research Ethics Review Guideline (2014), The IRB expects investigators to report the SAE and measures taken to manage within 48 h of occurrence of the event, even if the SAE is considered not to be related to the research procedures. Investigators are also expected to make follow up reports.
Link
