Polaris

CompanyStandard Operating Procedure: SITE-002.0Title: Training Study Site Clinical Research StaffEffective 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. Purpose• To ensure all staff members involved in clinical research are properly trainedconcerning FDA regulations, ICH guidelines, and company policies and procedures.• To describe the process for continuous employee training.• To describe the procedures for maintaining documentation of initial training andcontinuing education.II.ScopeThis SOP applies to all employees and independent contractors for Company.SITE-002.0.doc© 2004 by CRC Press LLC