DSM

帝斯曼

• 批准号: 7726766
• 负责人: Gina R. Petroni
• 金额: $ 4.37万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7726766
• 关键词: Adherence; Adverse event; Charge; Clinical Trials; Data; Frequencies; Guidelines; Malignant Neoplasms; Monitor; Pattern; Protocols documentation; Rate; Research Infrastructure; Research Personnel; Review Committee; Safety; University of Virginia Cancer Center; drinking

Within the University of Virginia Cancer Center, the Protocol Review Committee, and the Data and Safety Monitoring Committee provide the infrastructure for scientific oversight and monitoring of institutional cancer related clinical trials. The Data and Safety Monitoring Committee provides oversight of the conduct of all ongoing UVa investigator-initiated clinical trials that have been approved by the Protocol Review Committee. For those studies the committee is charged with monitoring, their duties include review of study specific data and safety monitoring plans; adverse events including frequency and patterns of adverse events; protocol violations; audit findings; accrual rates; and adherence to protocol specific escalation or deescalation guidelines, or early stopping guidelines. The protocol specific risk.level assigned by the Protocol Review Committee determines the degree of monitoring.

在弗吉尼亚大学癌症中心，协议审查委员会以及数据以及 安全监测委员会为科学监督和监测机构提供基础设施 与癌症相关的临床试验。数据和安全监测委员会对行为进行监督 在所有正在进行的UVA研究者发起的临床试验中，该试验已获得协议审查 委员会。对于这些研究，委员会负责监视，他们的职责包括研究审查 具体数据和安全监控计划；不良事件，包括不利的频率和模式 事件；违反协议；审核发现；应计率；并遵守协议特定的升级或降级 指南或早期停止准则。协议特定风险。协议分配的级别 审查委员会确定监控程度。