Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 8231149
• 负责人: MICHAEL J. WEBER
• 金额: $ 6.59万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-02-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8231149
• 关键词: Cancer Center; Cancer Center Support Grant; Charge; Clinical Research; Clinical Trials; Ensure; Goals; Guidelines; Human; Instruction; Malignant Neoplasms; Mediating; Monitor; Play; Protocols documentation; Research Personnel; Review Committee; Role; System; United States National Institutes of Health; Universities; University of Virginia Cancer Center; Virginia; anticancer research; authority; cancer research center director; design; human subject; research study; sound

The Cancer Center Protocol Review and Monitoring System oversees and ensures the scientific merit, priorities, and progress of all cancer clinical studies conducted at the University of Virginia (UVA). A Protocol Review Committee (PRC), appointed by the UVA Cancer Center Director and administratively-supported by the Office for Clinical Research, has been given the authority and charge to carry out this mandate. The PRC is chaired by James Larner, MD. Its primary goal is to ensure that investigator- and industryinitiated cancer research studies involving human subjects conducted at the UVA Cancer Center are: (1) scientifically and statistically sound; (2) appropriately designed; (3) feasible for completion; and (4) in compliance with NIH guidelines for human studies. The PRC also plays an important role in mediating competing studies by requiring an agreed upon institutional prioritization plan, and closely monitors the accrual progress of studies.

癌症中心方案审查和监测系统监督并确保科学价值， 优先事项，以及在弗吉尼亚大学（UVA）进行的所有癌症临床研究的进展。的协议 审查委员会（PRC），由UVA癌症中心主任任命，并由 临床研究办公室已被赋予执行这一任务的权力和责任。 PRC由James Larner，MD担任主席。其主要目标是确保调查人员和行业发起的 在UVA癌症中心进行的涉及人类受试者的癌症研究包括：（1） （2）设计合理;（3）可完成;（4） 符合NIH人体研究指南。 PRC在调解竞争性研究方面也发挥着重要作用，要求各方同意 教育部还制定了机构优先事项计划，并密切监测研究的累积进展情况。