Adverse Event Reporting

Adverse Event Reporting. The Sponsor and all Investigators shall comply with all applicable adverse event reporting requirements as set forth in 21 CFR Parts 312 and 314 for drugs, 21 CFR Part 803 for medical devices, and ICH E2A guidelines for clinical safety data management. All serious adverse events (SAEs) shall be reported to the Sponsor within twenty-four (24) hours of the Investigator first becoming aware of the event. An SAE is defined as any adverse event that results in: death, a life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or any event that requires medical or surgical intervention to prevent one of the above outcomes. The Sponsor shall submit IND Safety Reports to the FDA and all participating Investigators within fifteen (15) calendar days of receiving the SAE report, or within seven (7) calendar days for events that are both serious and unexpected and associated with the use of the investigational product where the event is fatal or life-threatening. All adverse events, regardless of severity, shall be documented, assessed for causality, and followed until resolution or stabilization.