Data Safety and Monitoring

数据和安全监测计划（DSMP）由H。Lee Moffitt癌症中心和研究 该研究所最初于2002年确保由癌症中心进行或协调的所有临床研究都是 科学地精心设计，负责任地管理，适当地报告，并保护权利， 人类参与者的福利。机构计划符合NIH和NCI的政策和指导方针 关于数据和安全监测。监测的特点和程度是个性化的每一个 根据个体参与者的风险程度和临床研究的复杂性， research.由于具体的监查和报告类型因个体试验的性质而异， 确保监测适当、及时和有效的责任包括一些癌症 中心组。临床研究副中心主任全面负责数据 和安全监测。在数据和安全性监测方面发挥作用的其他实体包括： 研究者（PI）和研究团队;临床研究运营（CRO）部门;机构 方案监查委员会（PMC）;外部数据安全性监查委员会（DSMB）（如适用）; 研究合规-企业合规办公室;以及南佛罗里达大学 审查委员会（USF IRB）。 PMC由Pamela Munster博士担任主席，负责审查研究团队提交的所有中期报告，以确保 研究是按照书面规定进行的。PMC还审查临床试验提交的稽查报告 公司合规部研究合规部的审计员，以确保 方案治疗依从性和法规要求依从性。监测和审计 两个职能部门向癌症中心的两个不同实体报告，以确保适当的制衡。

The Data & Safety Monitoring Plan (DSMP) adopted by the H. Lee Moffitt Cancer Center & Research Institute originally in 2002 ensures that all clinical research conducted or coordinated by the Cancer Center is scientifically well designed, responsibly managed, appropriately reported, and that it protects the rights and welfare of human participants. The institutional plan conforms to NIH and NCI policies and guidelines regarding data and safety monitoring. The characteristics and degree of monitoring is individualized for each study according to the degree of risk involved to the individual participants and the complexity of the clinical research. As the specific types of monitoring and reporting will vary by the nature of the individual trial, the responsibility for ensuring that monitoring is appropriate, timely and effective includes a number of Cancer Center groups. The Associate Center Director for Clinical Investigations holds overall responsibility for data and safety monitoring. Other entities that have a role in data and safety monitoring include: Principal Investigators (PI) and study teams; the Clinical Research Operations (CRO) department; the Institutional Protocol Monitoring Committee (PMC); External Data Safety Monitoring Board (DSMB) (if applicable); the Research Compliance - Corporate Compliance Office; and the University of South Florida Institutional Review Board (USF IRB). The PMC, chaired by Dr. Pamela Munster, reviews all interim reports submitted by the study team to ensure that the study is being conducted as written. The PMC also review audit reports submitted by clinical trial auditors in the Research Compliance Division of the Corporate Compliance Department to assure compliance with protocol treatment and adherence to regulatory requirements. The monitoring and auditing functions report to two different entities in the Cancer Center to ensure appropriate checks and balances.