Polaris

CompanyStandard Operating Procedure: MON-002.0Title: Training 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. PurposeScope• To ensure all clinical monitoring staff members are trained concerning FDAregulations, 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.This SOP applies to all employees and independent contractors for Company.MON-002.0.doc© 2004 by CRC Press LLC