What regulatory reports does the postmarket pharmacovigilance module produce?

Individual case safety reports (ICSRs) in E2B(R3) electronic format, MedWatch 3500A forms for FDA submission, CIOMS I reports for international submission, DSURs (Development Safety Update Reports) for trials in active development, and PSURs (Periodic Safety Update Reports) for marketed drugs. Real-time case processing covers time-sensitive reporting timelines (7-day expedited for fatal or life-threatening unexpected; 15-day expedited for other serious unexpected).