DATA SAFETY AND MONITORING BOARD

丹L邓肯癌症中心（DLDCC）的最高优先级是确保安全的， 参与临床试验的患者。主要研究者（PI）主要负责 监督，但额外的安全措施包括综合科学，安全和伦理审查， 监测与质量保证审计相结合。临床研究的主要监督 在DLDCC进行的与临床试验启动、监查和终止相关的研究 由（1）方案审查和监测委员会（PRMC）监督，（2）数据审查 委员会（DRC）;（3）患者安全官（PSO），确保所有数据监测 癌症中心试验按照批准的监测计划进行。每个DLDCC 研究方案必须有数据和安全性监测计划，并由 患者入组前的PRMC。可以完成对DLDCC协议的协议监视 包括：NCI合作组数据和安全审查委员会， 由制药或学术赞助商建立的医学监查员或委员会 常设数据审查委员会或个人、方案特定数据和安全性监查 板.委员会和PSO向临床研究领导委员会报告 在DLDCC内部，并最终向癌症中心主任报告。

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.