DATA SAFETY AND MONITORING BOARDS

数据安全和监控委员会

• 批准号: 7944800
• 负责人: John Sarantopoulos
• 金额: $ 2.25万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-03 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944800
• 关键词: Adherence; Adverse event; Cancer Center; Charge; Clinical Research; 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; Therapeutic Studies; 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

为了确保数据安全和监测委员会的最高水平安全安全和研究质量 （DSMC）负责监视，审查和将行政管理视为 需要在癌症中心内的所有研究研究中。所有研究都受到监测，直到每个适合 完成的治疗和随访。 DSMC监督研究数据有效性的所有方面 完整性，确保监管合规性并保护所有癌症中心参与者的安全性 研究。 P30研究行政办公室（ORA）是癌症中心共享资源，提供 支持DSMC。 ORA的质量保证部门负责指导质量 保证（QA）审核的重点是验证数据准确性，能够合格和协议合规性。 ORA收集与研究相关的信息并为DSMC行动提供报告，并确保 DSMC规定的纠正措施已完成。 DSMC主席向吉尔斯博士报告了P30 副主任。 ORA工作人员进行的监督和监测激活以及由DSMC监督的包括： 监视所有研究中的研究参与者的安全 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准确性和有效性 验证遵守癌症中心数据和安全监控计划（DSMP） 确保纠正措施并遵守质量检查报告和发现 确保遵守不良事件（AE）报告要求 审查AE趋势 验证需要DSMB的研究是否存在 确保适当地报告了研究的末端和暂停 分配优先级审核水平分数（PAL） 审查功效率并确保执行停止规则