DATA SAFETY AND MONITORING BOARDS

数据安全和监控委员会

• 批准号: 8320972
• 负责人: John Sarantopoulos
• 金额: $ 2.16万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8320972
• 关键词: Adherence; Adverse event; Cancer Center; Charge; Clinical Research; Clinical Trials Data Monitoring Committees; Data; Data Quality; Data Reporting; Eligibility Determination; Ensure; Monitor; NCI Center for Cancer Research; Participant; Protocol Compliance; Reporting; Research; Research Design; Resource Sharing; Role; Safety; Suspension substance; Suspensions; cancer therapy; follow-up; patient safety; quality assurance; ranpirnase; safety study; trend

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

为了确保最高水平的安全和研究质量，数据安全和监测委员会 (Dsmc)负责监督、审查和处理行政行为。 癌症中心内的所有ACE5研究都需要。所有的研究都受到监控，直到每个病人 完成治疗及随访研究。数据管理中心监督研究数据有效性的所有方面，并 诚信，确保法规遵从性，并保护所有癌症中心临床参与者的安全 学习。P30研究管理办公室(ORA)是癌症中心的共享资源，提供 对dsmc的支持。ORA的质量保证部门负责进行质量管理 保证(QA)审计，重点是验证数据准确性、合格和协议合规性。 ORA收集与研究相关的信息，并为DSMC行动生成报告，并确保 完成了dsmc规定的纠正措施。DSMMC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： 监测所有研究中参与者的安全性 审查研究参与者的资格 确保协议合规性 验证参与者信息的完整性以及数据的准确性和有效性 验证对癌症中心数据和安全监测计划(DSMP)的遵守情况 确保纠正措施并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 声发射的发展趋势综述 验证需要DSMB的研究是否已到位 确保适当地报告终止和暂停研究 分配审核级别分数(PALS)的优先级 审查有效率并确保停药规则得到执行