Polaris

CompanyMeeting with InvestigatorDid the Monitor meet with the Investigator to discussthe following:Yes No Comment57. Accomplishments of the study site58. Remaining problems or issues and corrective actionsneeded59. Investigator obligations concerning records retention60. Final payment policy61. Publication policy62. What to expect in the event of an FDA inspection63. Notify Company as soon as possible if the site isalerted that an inspection by the FDA is impendingWere all Action Items in the previous trip report accomplished? Yes NoIf “no,” repeat outstanding items in section below.Action ItemsAction needed Person responsible Date dueAdditional Comments/ObservationsSignature of person who conducted the visitDateTrip Rpt Termination.doc© 2004 by CRC Press LLC