Regulatory Affairs Officer 4. Review by Sponsor/Investigator if need be for FDA and Med Watch ADVERSE EVENT SERIOUS § Results in death § Is life-threatening § Requires inpatient hospitalization or prolongation of existing hospitalization § Results in significant disability or incapacity § Results in congenital anomaly or birth defect § Causes cancer § Is an overdose § Any medical event which requires treatment to prevent one of the medical outcomes listed above NON- SERIOUS EXPECTED UNRELATED RELATED Annual Progress Report/Continuing Review Annual Progress Report/Continuing Review UNEXPECTED RELATED REPORT IN WRITING WITHIN 48 HOURS: 1. Local IRB 2.