CORE--Protocol Review

核心——协议审查

• 批准号: 7109841
• 负责人: Grover Carlton Bagby
• 金额: $ 3.85万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-05 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7109841
• 关键词: biomedical facility; clinical trials; health science research; method development; neoplasm /cancer

The mission of the Protocol Review and Monitoring System (PRMS) is to provide internal oversight of all cancer clinical trials conducted at the OHSU Cancer Institute (CI) to ensure both scientific integrity and the protection of human subjects through the course of the clinical research process. The PRMS includes initial scientific protocol review, real-time monitoring of protocol activity, monthly cumulative report review, annual review and final review. All components of the PRMS at the Cancer Institute are the responsibility of the Clinical Research Review Committee (CRRC). The CRRC is charged by the CI Director to ensure that all clinical trials and cancer-related research conducted at the Institute are: 1) scientifically meritorious; 2) appropriately designed and statistically validated; 3) feasible for completion within the specified time frame; 4) in compliance with FDA and NIH guidelines for clinical trials; and, 5) compatible with the priorities, goals, and interests of the Institute. The functions of the CRRC are independent of the OHSU Institutional Review Board (IRB) and the Data and Safety Monitoring Committee (DSMC). The CRRC Chair is Craig Nichols MD. The Director of Clinical Research Management, Margaret McMahon MN ANP, is CRRC co-chair and administers the PRMS.

方案审查和监测系统（PRMS）的使命是对OHSU癌症研究所（CI）进行的所有癌症临床试验进行内部监督，以确保科学完整性和在临床研究过程中保护人类受试者。PRMS包括初始科学方案审查、方案活动实时监测、月度累积报告审查、年度审查和最终审查。所有 癌症研究所PRMS的组成部分由临床研究审查委员会（CRRC）负责。CRRC由CI主任负责，以确保在研究所进行的所有临床试验和癌症相关研究：1）科学上有价值; 2）适当设计和统计验证; 3）在指定的时间范围内完成可行; 4）符合FDA和NIH临床试验指南; 5）符合研究所的优先事项，目标和利益。CRRC的职能是 独立于OHSU机构审查委员会（IRB）和数据和安全性监测委员会（DSMC）。CRRC主席是医学博士克雷格尼科尔斯。临床研究管理总监Margaret McMahon MN ANP是CRRC的联合主席，负责管理PRMS。