Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 9149095
• 负责人: Linda Lee Garland
• 金额: $ 6.68万
• 依托单位: UNIVERSITY OF ARIZONA
• 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/9149095
• 关键词: Arizona; Basic Science; Cancer Center; Cancer Center Support Grant; Charge; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Data Monitoring Committees; Committee Membership; Data; Development; Electronics; Ensure; Feedback; Funding Agency; Future; Logistics; Malignant Neoplasms; Mission; Monitor; Outcome; Patient Monitoring; Patients; Peer Review; Performance; Population Sciences; Principal Investigator; Process; Protocols documentation; Recommendation; Research; Resources; Review Committee; Risk; Safety; Shapes; Specialist; Specific qualifier value; System; United States National Institutes of Health; Universities; abstracting; authority; base; cancer clinical trial; cancer prevention; cancer therapy; expedited review; improved; meetings; multidisciplinary; therapeutic development

Project Summary / Abstract: Protocol Review and Monitoring System (PRMS) The conduct of cancer clinical trials is central to the scientific mission of the University of Arizona Cancer Center (UACC). The development and implementation of a broad portfolio of cancer trials requires an extensive institutional commitment of scientific, operational, and patient resources; thus, oversight of the scientific merit and progress of the trial portfolio is paramount in ensuring that trial outcomes help shape the future of cancer prevention and treatment. The internal oversight of the scientific aspects of all cancer trials and the monitoring of the progress of cancer trials research is managed by the UACC Protocol Review and Monitoring System (PRMS). The Scientific Review Committee (SRC) serves as the principal functional component of the PRMS; it is the chartered, multidisciplinary body charged with the ultimate review of the scientific merit, prioritization, and progress of all cancer trials proposed by UACC Principal Investigators, with the exception of those trials that have undergone external peer-review through NIH and its funding agencies. The SRC membership is composed of a broad spectrum of specialists in cancer treatment, cancer prevention, therapeutic development, and basic and population science that mirrors the breadth of the UACC's clinical trial portfolio. Cancer trials are risk-stratified for determination of need for full Committee versus administrative expedited review. A systematic process is in place for the monitoring of accrual to trials and of trial scientific progress. The SRC has the authority to terminate trials that have not met pre-specified accrual targets or that are not meeting their scientific objectives. The PRMS performance metrics are generated by the clinical research system OnCore® and provide the basis for PRMS quality improvement initiatives.

项目摘要/摘要：方案审查和监测系统（PRMS） 进行癌症临床试验是亚利桑那大学癌症科学使命的核心 中心（UACC）。开发和实施广泛的癌症试验组合需要 广泛的科学，运营和患者资源的机构承诺;因此，监督 试验组合的科学价值和进展对于确保试验结果有助于塑造 癌症预防和治疗的未来。对所有癌症试验的科学方面进行内部监督 癌症试验研究进展的监测由UACC协议审查管理， 监测系统（PRMS）。科学审查委员会（SRC）作为主要职能机构， PRMS的组成部分;它是特许的，多学科的机构，负责最终审查 UACC主要研究者提出的所有癌症试验的科学价值、优先顺序和进展， 通过NIH及其资助机构进行外部同行评审的试验除外。 SRC成员由癌症治疗，癌症预防， 治疗开发，以及反映UACC临床试验广度的基础和人口科学 portfolio.癌症试验是风险分层的，以确定是否需要完全委员会或管理委员会 快速审查。有一个系统的程序来监测试验的累积和试验的科学性。 中求进工作总SRC有权终止未达到预先规定的累积目标或 没有达到他们的科学目标。PRMS性能指标由临床 研究系统OnCore®，并为PRMS质量改进计划提供基础。