Polaris

CompanyStandard Operating Procedure: MON-006.0Title: Conducting Study Initiation 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 a StudyInitiation Visit. The purpose of a Study Initiation Visit is:• To review with the Investigator and staff the final protocol, the Investigator’sBrochure and regulatory requirements, and• To instruct study personnel in study procedures including, but not limited to patientrecruitment, informed consent, drug dispensing and accountability, and Case ReportForm completion.MON-006.0.doc© 2004 by CRC Press LLC