Polaris

CompanyStandard Operating Procedure: MON-005.0Title: Conducting Site Evaluation 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 performed during a Site Evaluation Visit.The purpose of a Site Evaluation Visit is to evaluate:• The ability of a study site to successfully conduct the proposed clinical trial;• The credentials of study personnel; and• The adequacy of clinic facilities.II.ScopeThis SOP will apply to all Site Evaluation Visits being conducted by Company personnel.MON-005.0.doc© 2004 by CRC Press LLC