Polaris

CompanyStandard Operating Procedure: MON-008.0Title: Reviewing Case Report Forms at the Study SiteEffective 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 standardize procedures for review of Case Report Forms (CRFs) retrieved fromclinical study sites and to establish a comprehensive plan for routing the CRFs fromretrieval through submission to Data Management.II.ScopeThis SOP will apply to all CRFs being processed by Company personnel.MON-008.0.doc© 2004 by CRC Press LLC