PROTOCOL REVIEW AND MONITORING SYSTEM (Core-010)

方案审查和监测系统（Core-010）

• 批准号: 10260737
• 负责人: Carlos L Arteaga
• 金额: $ 8.01万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-03 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10260737
• 关键词: Cancer Center; Cancer Center Support Grant; Cancer Control; Clinical; Clinical Cancer Center; Clinical Oncology; Clinical Research; Clinical Trials; Data; Ensure; Goals; Institutional Review Boards; Malignant Neoplasms; Medical center; Monitor; Peer Review; Population Sciences; Population Study; Protocols documentation; Reporting; Research; Review Committee; Safety; Services; System; Time; anticancer research; authority; cancer clinical trial; meetings

Harold C. Simmons Cancer Center Protocol Review and Monitoring System (PRMS) Project Summary/Abstract The goal of the Protocol Review and Monitoring System (PRMS) is to ensure the highest scientific quality of clinical oncology research at UTSW and consists of three Cancer Center Protocol Review and Monitoring Committees (PRMCs), the Data and Safety Monitoring Committee (DSMC), and the administrative support services of the Clinical Research Office. These entities are overseen by the Clinical Cancer Research Committee, which reports to the Cancer Center's Deputy Director. The SCC has three PRMCs; two “general” committees, each of which meets monthly, and one reserved for Population Studies. PRMC1 and PRMC2 have the same responsibilities, but were created with staggered meeting dates so as to allow more timely review and approval of new protocols. The Population Sciences PRMC is responsible for protocols related to Population Sciences and Cancer Control. The three PRMCs review and monitor all cancer-related clinical studies for scientific merit prior to IRB review. The PRMCs have the authority to open protocols that meet the scientific merit and scientific priorities of the SCC, and to close protocols that do not demonstrate scientific progress. The focus of the PRMCs is on scientific merit, study prioritization, and progress of Cancer Center clinical trials. Studies which have already undergone rigorous peer review at the national level, such as NCI-approved national cooperative group studies are reviewed administratively by the PRMC Chair.

哈罗德·西蒙斯癌症中心 协议审查和监测系统(PRMS) 项目摘要/摘要 议定书审查和监测系统的目标是确保最高的科学质量 UTSW的临床肿瘤学研究，由三个癌症中心方案审查和监测组成 各委员会(PRMC)、数据和安全监测委员会(DSMC)以及行政支助 临床研究室的服务。这些实体由临床癌症研究中心监督 该委员会向癌症中心的副主任报告。SCC有三个PRMC；两个“将军” 委员会，每个委员会每月开会，一个预留给人口研究。PRMC1和PRMC2 职责相同，但会议日期错开，以便更及时地 审查和批准新的议定书。人口科学PRMC负责与以下内容相关的协议 人口科学与癌症控制。 在IRB审查之前，三个PRMC审查和监测所有与癌症相关的临床研究的科学价值。 PRMC有权开放符合科学价值和科学优先事项的议定书 SCC，并关闭不能证明科学进步的方案。临立会的工作重点是 癌症中心临床试验的科学价值、研究优先顺序和进展。已经进行过的研究 在国家一级接受了严格的同行审查，例如国家合作委员会批准的国家合作小组研究 由PRMC主席进行行政审查。