Polaris

SOP# SITE-013.0E. Sponsor ContactsCompanyEffective Date: DD/MMM/YY1. Telephone Contacts – All study personnel will document critical conversationswith the Sponsor/CRO, especially those pertaining to eligibility criteria, protocoldeviations, and serious adverse experiences. Unless the Sponsor/CRO hasrequested that another method be used, the Telephone Contact Report form willdocument these discussions (Attachment B). The Study Coordinator or delegatewill file the Telephone Contact Reports in the Regulatory Documents Binder.2. Letters and Faxes – All study personnel will make copies of all correspondencewritten to the Sponsor/CRO. The Study Coordinator or delegate will file thiscorrespondence in the Regulatory Documents Binder.3. E-mails – All study personnel will print out copies of critical e-mails with theSponsor/CRO. The Study Coordinator or delegate will file this correspondence inthe Regulatory Documents Binder.4. At a minimum, the Sponsor/CRO should be notified:a. When the first subject is enrolled in the study.b. When there is a question concerning a potential subject’s eligibility.c. When recruitment issues occur.d. When a protocol violation occurs.e. When an SAE occurs.IV.ReferencesNoneV. AttachmentsAttachment A – Monitoring LogAttachment B – Telephone Contact ReportSITE-013.0.doc© 2004 by CRC Press LLC