Polaris

Company14. Are there any issues concerning the reporting oflaboratory results?15. Did the Monitor meet with the Investigator to discussthe findings at this visit?16. Does the Principal Investigator continue to beinvolved in the study?Yes No N/A CommentInformed ConsentYes No Comment17. Were the informed consents reviewed for all new subjectsenrolled in the study?18. Were the informed consents present for all new screenfailures?19. Are the correct versions of the consent forms being signed bystudy subjects?20. Have all new subjects and screen failures signed the consentform before any study-related assessments were made?21. Were any consent forms unsigned or unavailable for review?22. Informed consents were checked for the following subjects:Case Report Form ReviewYes No Comment23. Are CRFs being competed in a timely manner?24. Are there any issues concerning accessibility to sourcedocuments?25. Have all of the retrieved CRFs been signed by theInvestigator?26. Were the data in the CRFs verified against the sourcedocuments?27. Were the all requested data clarifications made at the time ofthe visit?28. Source documents for the following CRFs were reviewedSubject #SubjectInitialsStudy Visits or CRF pagescheckedCommentTrip Rpt Interim.doc© 2004 by CRC Press LLC