CORE--DATA & SAFETY MONITORING

核心--数据

• 批准号: 7310767
• 负责人: MARK A SOCINSKI
• 金额: $ 4.15万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7310767
• 关键词: biomedical facility; clinical trials; data quality /integrity; human subject; neoplasm /cancer therapy; patient safety /medical error

The UNC Lineberger Comprehensive Cancer Center is committed to the safety of patients participating in clinical trials. The UNC Lineberger is also committed to protocol compliance and data accuracy. In support of these commitments, the Cancer Center has established and implemented an institutional Data and Safety Monitoring Plan to assure data and safety monitoring for Cancer Center clinical trials. The National Cancer Institute reviewed and approved this plan in 2001. The Center has also established the Oncology Protocol Audit Committee and process to review UNC LCCC institutional clinical trials. The Data and Safety Monitoring Committee (DSMC), led by Dr. Mark Socinski, is the primary agent for data and safety monitoring. The Committee, which meets monthly, has oversight for all oncology clinical trials conducted in association with the UNC Lineberger. The DSMC reports findings to the Protocol Review Committee, which reviews and forwards these reports and makes recommendations to the UNC Chapel Hill School of Medicine's Committee for the Protection of the Rights of Human Subjects (SOM-IRB) and to the School's Data and Safety Monitoring Board (SOM-DSMB). The level of data and safety monitoring for a trial depends upon the risk to the patients and the complexity of the trial. The Oncology Protocol Audit Committee (OPAC) audits institutional clinical trials for data accuracy and completeness. Dr. Lisa Carey, a medical oncologist, chairs the Committee. All institutional clinical trials with ongoing accrual are audited once per year following their initial IRB approval anniversary. Audits are held four times a year (December, March, June, and September) and conducted by Cancer Center members from disease groups different than the protocols being audited. Audit findings are submitted to OPAC, which determines ratings and actions and reports to the Protocol Review Committee and to the Principal Investigators. The PRC reports substantial and/or serious protocol deviations to the UNC Lineberger Associate Director for Clinical Research, the UNC Lineberger Director, the SOM-IRB, and to the trial sponsors.

北卡罗来纳大学莱恩伯格综合癌症中心致力于确保参与临床试验的患者的安全。北卡罗来纳大学莱恩伯格还致力于协议合规性和数据准确性。为了支持这些承诺，癌症中心制定并实施了机构数据和安全监测计划，以确保癌症中心临床试验的数据和安全监测。美国国家癌症研究所于 2001 年审查并批准了该计划。该中心还设立了肿瘤方案审计委员会和审查北卡罗来纳大学 LCCC 机构临床试验的流程。由 Mark Socinski 博士领导的数据和安全监测委员会 (DSMC) 是数据和安全监测的主要代理机构。该委员会每月举行一次会议，负责监督与北卡罗来纳大学莱恩伯格联合开展的所有肿瘤学临床试验。 DSMC 向协议审查委员会报告调查结果，该委员会审查并转发这些报告并向北卡罗来纳大学教堂山分校提出建议 医学院人类受试者权利保护委员会 (SOM-IRB) 以及学院数据和安全监测委员会 (SOM-DSMB)。试验的数据和安全监测水平取决于患者的风险和试验的复杂性。 肿瘤方案审核委员会 (OPAC) 审核机构临床试验的数据准确性和完整性。委员会主席是医学肿瘤学家 Lisa Carey 博士。所有持续累积的机构临床试验在其最初的 IRB 批准周年纪念日后每年都会进行一次审核。审核每年举行四次（十二月、三月、六月和九月），由来自与被审核方案不同的疾病组的癌症中心成员进行。审计结果提交给 OPAC，由 OPAC 确定评级和行动，并向方案审查委员会和主要研究者报告。 PRC 向 UNC Lineberger 临床研究副主任、UNC Lineberger 主任、SOM-IRB 和试验申办者报告重大和/或严重的方案偏差。