DATA SAFETY AND MONITORING BOARD

丹·L·邓肯癌症中心 (DLDCC) 将确保患者的安全放在首位 参与临床试验的患者。首席研究员 (PI) 主要负责 监督，但额外的安全措施包括综合科学、安全和伦理审查以及 监测与质量保证审核相结合。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 由 (1) 方案审查和监测委员会 (PRMC)、(2) 数据审查监督 委员会（刚果民主共和国）； (3) 一名患者安全官员 (PSO)，确保所有数据监控 癌症中心试验是按照批准的监测计划进行的。每个 DLDCC 方案必须有数据和安全监测计划，并由监管机构审查和批准 PRMC 在患者入组之前。可以完成对 DLDCC 协议的协议监控 通过多种机制，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 DLDCC 设立的医疗监督员或委员会 常设数据审查委员会或个人、特定于方案的数据和安全监测 董事会。委员会和 PSO 向临床研究领导委员会报告 在 DLDCC 内，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.