DATA SAFETY AND MONITORING BOARD

丹·L邓肯癌症中心将确保患者的生命安全放在首位。 参与临床试验的患者。首席调查员(PI)主要负责 监督，但额外的安全措施包括综合的科学、安全和伦理审查以及 监控与质量保证审计相结合。临床研究的主要监督 在DLDCC进行的与临床试验的启动、监测和终止相关的是 由(1)议定书审查和监测委员会(PRMC)监督，(2)数据审查 委员会(DRC)；和(3)一名患者安全干事(PSO)，确保所有数据监测 癌症中心试验是根据批准的监测计划进行的。每个DLDCC 议定书必须有数据和安全监测计划，该计划由 PRMC在患者登记之前。可以完成对DLDCC协议的协议监控 通过几个机制，包括：NCI合作组数据和安全审查委员会， 由药品或学术赞助商DLDCC设立的医学监测或委员会 常设数据审查委员会或个别、特定于议定书的数据和安全监测 冲浪板。这些委员会和PSO向临床研究领导委员会报告 在DLDCC内并最终提交给癌症中心主任。

The Dan L Duncan Cancer Center (DLDCC) places the highest priority on ensuring the safety of patients participating in clinical trials. The Principal Investigator (PI) has primary responsibility for oversight, but additional safety measures include integrated scientific, safety and ethical review and monitoring coupled with quality assurance audits. The primary oversight of clinical research conducted at DLDCC as related to the Initiation, monitoring and termination of clinical trials Is overseen by (1) the Protocol Review and Monitoring Committee (PRMC), (2) Data Review Committees (DRC); and (3) a Patient Safety Officer (PSO) who ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved monitoring plan. Each DLDCC protocol must have a data and safety monitoring plan, which is reviewed and approved by the PRMC prior to patient enrollment. Protocol monitoring for DLDCC protocols may be accomplished by several mechanisms Including: NCI Cooperative Group data and safety review committees, medical monitors or committees established by a pharmaceutical or academic sponsor, DLDCC standing Data Review Committees or by individual, protocol-specific Data and Safety Monitoring Boards. The committees, and the PSO, report to the Clinical Research Leadership Committee within the DLDCC and ultimately to the Cancer Center Director.