Polaris

CompanyStandard Operating Procedure: MON-010.0Title: Adverse Experiences (AEs), Serious AdverseExperiences (SAEs), and IND Safety ReportsEffective Date: DD/MMM/YYSupersedes: N/AAUTHORName:Title:Department:Signature and Date:APPROVED BY DEPARTMENT HEAD QUALITY ASSURANCEName:Title:Department:Signature and Date:REVISIONSNo. Section Pages Initials/DateI. PurposeTo describe the processes involved in the receipt, evaluation, and reporting of non-seriousand serious adverse experiences (SAE) occurring in clinical trial subjects.II.ScopeThis SOP will apply to all clinical trials involving non-marketed products.MON-010.0.doc© 2004 by CRC Press LLC