Data Safety and Monitoring

H.Lee Moffitt癌症研究中心采用的数据和安全监测计划 该研究所最初成立于2002年，确保由癌症中心进行或协调的所有临床研究 科学设计，负责任的管理，适当的报道，并保护权利和 人类参与者的福利。机构计划符合NIH和NCI的政策和指南 关于数据和安全监测。每种监测的特点和程度都是个性化的 根据个体参与者所涉及的风险程度和临床复杂性进行研究 研究。由于监测和报告的具体类型将因个别试验的性质而异， 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对数据负有全面责任 和安全监控。在数据和安全监测方面发挥作用的其他实体包括： 研究人员(PI)和研究团队；临床研究操作部(CRO)；机构 协议监测委员会(PMC)；外部数据安全监测委员会(DSMB)(如果适用)； 研究合规-企业合规办公室；以及南佛罗里达大学机构 审查委员会(USF IRB)。 PMC由Pamela Munster博士担任主席，负责审查研究小组提交的所有中期报告，以确保 这项研究正在按书面形式进行。PMC还审查临床试验提交的审计报告 公司合规部研究合规部审计师确保 遵守礼仪治疗和遵守法规要求。监督和审计 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.