4e1da73d_igilance_System_at_SJ_Pharmaco__Scope
[Number] DS-001 [Title] Processing Adverse Events and SAEs [Scope] 
The scope of this SOP is 1) Processing of postmarketing adverse events from any source, including but not limited to spontaneous reporting sources, active literature surveillance, phase IV studies, patient registries, patient assistance programs, and 2) Processing of serious adverse event reports from client-sponsored phase I, II, and III studies. This SOP begins with the receipt of a potentially valid adverse event report and ends with the appropriate reporting of the adverse event information to stakeholders. Processing of non-serious adverse event reports from company-sponsored phase I, II, and III studies is out of the scope of this SOP.
PV SOPs - Pharmacovigilance System at SJ Pharmaco
Scope