Polaris

CompanyStudy Termination Visit Trip ReportProtocol #: Investigator Name: Visit Date:Drug/Device: Institution Address: Visit Conducted By:Site Visit PersonnelList the study personnel who met with the Monitor during the visitName Study Role Screened:Final Enrollment StatusEnrolled:Ongoing:Completed:Discontinued:Monitoring ActivitiesComment required for all shaded answers.1. Were there any violations of the regulations since the last sitevisit?2. Were there any deviations from the eligibility criteria sincethe last site visit?3. Was the Subject Enrollment Log completed and a copyretrieved for Company files?4. Are any blank CRFs or study supplies remaining at the site?Yes No CommentInformed ConsentYes No Comment5. Were the informed consents reviewed for all subjects enrolledin the study?6. Were the informed consents present for all screen failures?7. Have all subjects and screen failures signed the consent formbefore any study-related assessments were made?8. Were any consent forms unsigned or unavailable for review?9. Informed consents were checked for the following subjects:Trip Rpt Termination.doc© 2004 by CRC Press LLC