During this fiscal year, one interim analysis of the phenobarbital clinical study data were performed for evaluation by the Performance and Safety Monitoring Committee. The system programs for monitoring patient status and data tracking have been modified to accommodate the change of the contract from a best-effort contract to a fee-for-deliverables contract. Accumulating data are continually being analyzed for consistency and for deviations from protocol using the BFSB H-P clinical trials computer management system. All edited data are transferred from the H-P to the DCRT, NIH computer where data analysis files are created and maintained.
