Polaris

CompanyStandard Operating Procedure: SITE-013.0Title: Interactions with the Sponsor orContract Research Organization (CRO)Effective 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 describe the interactions with the Sponsor or Contract Research Organization(CRO) and Company.• To ensure proper documentation of communications with the Sponsor/CROconcerning study activities.II.ScopeThis SOP will apply to all clinical trials conducted at Company.SITE-013.0.doc© 2004 by CRC Press LLC