Data and Safety Monitoring

项目总结（见说明）： 数据和安全监测 数据和安全监测委员会（DSMC）对HCCC的所有行业和机构协议进行严格审查。更具体地说，DSMC的主要职责是： 前瞻性筛选所有进入HCCC启动试验的患者，以确定试验指定的合格性。 研究协调员将填写完整的合格性检查表和检查结果提交给安全专员，由安全专员验证是否符合入选和排除标准。与DSMC主席和/或研究监查员讨论有关合格性的问题或顾虑。然后，在受试者入组试验之前，安全专员将DSMC批准、问题或顾虑传达给研究团队。 通过审查所有严重不良事件来评估安全性，并确保及时和适当地向监督机构（如NCI、FDA、IRB）报告 根据总体HCCC数据和安全性监测计划以及研究的风险水平，对选定的试验进行数据准确性、方案依从性和受试者安全性稽查。 如果安全性问题需要关闭，DSMC有权通过联系IRB关闭临床试验。

PROJECT SUMMARY (See instructions): Data and Safety Monitoring The Data and Safety Monitoring Committee (DSMC) provides rigorous review of all industry and institutional protocols at the HCCC. More specifically, the primary duties of the DSMC are to: ¿ prospectively screen all patients entering HCCC investigator-initiated trials for trial-specified eligibility. The study coordinator delivers a completed eligibility checklist, with test results, to the safety officer, who verifies that the inclusion and exclusion criteria are met. Questions or concerns about eligibility are discussed with the DSMC chair and/or the Study Monitor. The safety officer then communicates DSMC approval, questions or concerns to the research team before the subject is enrolled in the trial. ¿ assess safety by reviewing all severe adverse events and ensure timely and appropriate reporting to oversight agencies (e.g. NCI, FDA, IRB) ¿ conduct audits of selected trials for data veracity, protocol adherence, and subject safety based on overall HCCC Data and Safety Monitoring Plan and the risk level of the study. The DSMC has the authority to close a clinical trial by contacting the IRB should safety issues warrant such closure.