Since the last submission of this grant, the requirements for assurance of adherence to protocol-specific procedures and rules of human subjects' protection have increased. The requirements have been the result of national (FDA, OHRP, NCI) and local IRB policies. The NCI now requires that each Comprehensive Cancer Center develop an approved DSMP. We have significantly enhanced our monitoring and oversight activities and this has resulted in improved data quality and protocol adherence. However, these improvements have resulted in significant increases in personnel commitments and expense. The process we use for safety and protocol progress review is rigorous using a Clinical Trial Monitoring Review Committee meeting which meets weekly and reviews all active protocols for accrual, adverse events, and problems in 'real time'. The meetings are chaired by the Associate Director for Clinical Research and involve multiple clinical investigators, research nurses, data managers, pharmacy and regulatory staff. Weekly reports of safety/adverse events are referred to our Quality Assurance Committee (QAC) Director (Dr Carla Falkson) for review. Routine and 'for cause' audits are coordinated by the QAC with reports to the Center Director, IRB and regulatory agencies as appropriate.
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