Polaris

SOP# MON-003.0CompanyEffective Date: DD/MMM/YYH. Site Evaluation Visits will be scheduled to the institutions where potentialinvestigators appear to meet the pre-determined selection criteria. Some additionalinvestigators may be approved or eliminated on the basis of Site Evaluation Visitfindings.IV.References21 CFR 312.50 – General Responsibilities of Sponsors21 CFR 312.53 – Selecting Investigators and MonitorsICH Guidelines for Good Clinical Practice (E6) section 5.6 – Investigator SelectionICH Guidelines for Good Clinical Practice (E6) section 5.9 – FinancingICH Guidelines for Good Clinical Practice (E6) section 5.10 – Notification/Submission toRegulatory AuthoritiesV. AttachmentsNoneMON-003.0.doc© 2004 by CRC Press LLC