Polaris

CompanyStandard Operating Procedure: MON-007.0Title: Conducting Periodic Site VisitsEffective 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. PurposeThe purpose of this SOP is to describe the activities that will be accomplished at aPeriodic Site Visit. The purpose of a Periodic Site Visit is to ensure:• the study is being conducted according to the study protocol and to the principles ofGood Clinical Practice, and• all activities are in compliance with applicable FDA regulations and ICH guidelines,and• the facilities and staff at the investigational site continue to be acceptable for theconduct of the study.MON-007.0.doc© 2004 by CRC Press LLC