Polaris

CompanyIRB Progress Report Form (continued)Has the Principal Investigator, Subinvestigators, or Study Coordinatorchanged? Yes NoIf “yes,” explain:_______________________________________________Has the Principal Investigator, Subinvestigators, or Study Coordinatorreceived a revocation, sanction, or suspension of his/her state medicallicense since the study began? Yes NoIf “yes,” explain:_______________________________________________Has the FDA, OHRP, or other regulatory agency audited your site sincethis study was started? Yes NoIf “yes,” attach a copy of the 483 and your response.Summary of SAEsSubjectInitialsSubjectNumberNo SAEs have occurred.SAEOutcome of theSAESummary of GCP ViolationsSubjectInitialsSubjectNumberNo GCP violations have occurred.GCP ViolationPrincipal Investigator (print) Investigator’s Signature DateProgress Rpt.doc© 2004 by CRC Press LLC