Polaris

CompanySERIOUS ADVERSE EXPERIENCESSince the last monitoring visit the following SAEs have occurredNoneSAEStartDateStopDateRelationshipto drugExpected orUnexpectedOutcomeStudy DrugYes No Comment29. Was study drug inventory checked?30. Were there any problems with study drug inventory?31. Are study drug storage conditions appropriate?32. Are there any problems with the dosing schedule?33. Are there any problems with the blind?34. Are there any problems with drug expiration dates?35. Is an adequate supply of drug available?36. Are there any discrepancies between what wasdispensed to and returned from the subject?37. Are there any discrepancies between what wasdispensed to and returned from the pharmacy?38. Are there any discrepancies between what wasdispensed to and returned from the sponsor?39. Are there any issues with concomitant medications?40. Has any drug been returned or disposed of?REGULATORY DOCUMENTS AND STUDY-RELATED FORMSDo any of the following documents require follow-up or revision? Yes No Comment41. IRB membership list42. Laboratory certification43. Lab normal ranges44. FDA Form 157245. Curriculum vitae46. Financial disclosure47. Other:Trip Rpt Interim.doc© 2004 by CRC Press LLC