DATA AND SAFETY MONITORING

描述（由申请人提供）：自上次提交本拨款以来，确保遵守协议特定程序和人类受试者保护规则的要求有所增加。这些要求是国家（FDA、OHRP、NCI）和地方IRB政策的结果。NCI现在要求每个综合癌症中心制定一个批准的DSMP。我们大大加强了监测和监督活动，从而提高了数据质量和遵守协议的程度。但是，这些改进导致了人员承付和费用的大量增加。我们用于安全性和方案进展审查的过程是严格的，临床试验监测审查委员会每周召开一次会议，并“实时”审查所有有效的应计、不良事件和问题。会议由临床研究副主任主持，涉及多名临床调查员、研究护士、数据管理人员、药房和监管人员。安全/不良事件的每周报告将提交质量保证委员会（QAC）主任（Dr Carla Falkson）审查。例行审核和“因由”审核由质量保证中心（QAC）协调，并向质量保证中心报告

DESCRIPTION (provided by applicant): 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.