Data and Safety Monitoring

德克萨斯大学西南医学中心(UTSW)的数据和安全监测系统 西蒙斯癌症中心旨在确保癌症相关临床患者的安全和数据质量 审判。数据和安全监测委员会(DSMC)是一个独立委员会，由 癌症中心副主任，负责执行数据和安全监测计划 为癌症中心工作。Dsmc可以根据以下情况建议进行试验修改、暂停或关闭 安全或监管方面的担忧。暂停或关闭审判的建议通过以下方式实施 癌症中心和IRB的副主任。 Dsmc的基本功能包括： 审查和跟踪所有报告的癌症相关试验的SAE。 委员会对选定的不良事件进行全面审查。 所有机构治疗试验的年度系统性审查。 对治疗反应的独立评估。 发现潜在的合规违规行为。 每周监测毒性并对第一阶段试验的所有首次应计项目进行系统审查。 对10%与癌症相关的临床试验进行全面的文献审核。 在任何缺乏dsmc的治疗试验中充当dsmc。 该委员会的成员包括一名主席和联席主席，以及来自 生物统计学、护理、监管、药学和教职员工。教职员工是从所有肿瘤科中挑选出来的 治疗方式包括外科、放射肿瘤学和内科肿瘤学。Dsmc协调员提供 为所有dsmc活动和一名质量保证和教育协调员提供行政支持 进行内部审计。

The Data and Safety Monitoring System at the University of Texas Southwestern Medical Center (UTSW) Simmons Cancer Center is designed to ensure patient safety and data quality for cancer-related clinical trials. The Data and Safety Monitoring Committee (DSMC) is an independent committee appointed by the Deputy Director of the Cancer Center and is responsible for carrying out the data and safety monitoring plan for the Cancer Center. The DSMC can recommend trial modificafion, suspension, or closure based on safety or regulatory concerns. Recommendafions for trial suspension or closure are implemented through the Deputy Director of the Cancer Center and the IRB. The essenfial funcfions of the DSMC include: Review and tracking of all SAE's reported for cancer-related trials. Full committee review of selected adverse events. Annual systemafic review of all institufional therapeufic trials. Independent evaluation of treatment responses. Invesfigation of potential regulatory compliance violations. Weekly monitoring of toxicities and systematic review of all first accruals to Phase I trials. Comprehensive documentafion auditing for 10% of all cancer-related clinical trials. Serves as the DSMC for any therapeufic trial lacking a DSMC. The DSMC membership consists of a Chairperson and Co-Chairperson, and representation from biostafistics, nursing, regulatory, pharmacy, and faculty. Faculty members are selected from all the oncology treatment modalifies (Surgery, Radiation Oncology and Medical Oncology). A DSMC Coordinator provides administrative support for all of the DSMC activifies and a Quality Assurance & Educafion Coordinator conducts the internal audits.