CORE--Protocol Review

点击翻译按钮获取中文摘要

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.