DATA SAFETY AND MONITORING BOARDS

为了确保最高水平的患者安全和研究质量，数据安全和监测委员会 （DSMC）负责监督、审查和采取行政行动， 在癌症中心的所有ACFive研究中都需要。所有的研究都被监控，直到每一个病人 完成治疗和研究随访。DSMC监督研究数据有效性的各个方面， 完整性，确保合规性，并保护所有癌症中心临床参与者的安全 问题研究P30研究管理办公室（ORA）是一个癌症中心共享资源， 支持DSMC。ORA的质量保证部门负责执行质量 保证（QA）稽查，重点是验证数据准确性、合格性和方案合规性。 ORA收集与研究相关的信息，并为DSMC的行动编写报告，并确保 完成DSMC规定的纠正措施。DSMC主席向Giles博士报告，P30 副局长 由ORA工作人员进行并由DSMC监督的监督和监测活动包括： 监测所有研究中研究参与者的安全性 审查研究参与者的资格 确保方案依从性 确保参与者信息的完整性以及数据的准确性和有效性 遵守癌症中心数据和安全性监测计划（DSMP） 确保纠正行动和遵守质量保证报告和调查结果 确保遵守不良事件（AE）报告要求 审查AE趋势 证明需要DSMB的研究已经到位 确保适当报告研究终止和暂停 审计优先级评分（帕尔斯） 审查有效率并确保停止规则得到执行

To ensure the highest level of pafient safety and research quality, the Data Safety and Monitoring Committee (DSMC) is charged with the responsibility for monitoring, reviewing, and taking administrative acfion as needed on all acfive studies within the Cancer Center. All studies are monitored until every pafient has completed treatment and follow-up on study. The DSMC oversees all aspects of research data validity and integrity, ensures regulatory compliance, and protects the safety of participants in all Cancer Center clinical studies. The P30 Office of Research Administrafion (ORA) is a Cancer Center shared resource that provides support to the DSMC. The Quality Assurance Division of the ORA is responsible for conducfing quality assurance (QA) audits which focus on verifying data accuracy, pafient eligibility, and protocol compliance. The ORA collects research-related information and produces reports for DSMC action, and ensures that DSMC-mandated corrective actions are completed. The Chair of the DSMC reports to Dr. Giles, the P30 Deputy Director. Oversight and monitoring activifies conducted by ORA staff and supervised by the DSMC include: Monitoring the safety of study participants in all studies Reviewing eligibility of study participants Ensuring protocol compliance Verifying the completeness of participant information as well as data accuracy and validity Verifying adherence to the Cancer Center Data and Safety Monitoring Plan (DSMP) Ensuring corrective acfion and adherence to QA reports and findings Assuring compliance with adverse events (AE) reporting requirements Reviewing of AE trends Verifying that studies that require a DSMB have one in place Ensuring that the terminafion and suspension of studies are appropriately reported Assigning a Priority of Audit Level Score (PALS) Reviewing efficacy rates and ensuring that stopping rules are enforced