The YCC Protocol Review and Monitoring System (PRMS) provides critical oversight of all cancer clinical trials conducted in the YCC. The PRMS. is made up of three main elements, which include the Clinical Research Steering Committee (CRSC), the Protocol Review Committee (PRC), and the Quality Assurance, Compliance, and Safety Committee (QUACS). The CRSC and PRC are responsible for scientific prioritization and review of clinical trials prior to activation. The QUACS focuses on data and safety monitoring and closely monitors scientific progress, accrual of activated trials, overall quality control and patient monitoring, and deals with all issues relating to quality assurance and auditing. The QUACS functions and activities are described in more detail in Section 12. An Oversight Committee composed of the YCC Director and Senior Leadership provides a mechanism for appeal of decisions made through the PRMS. Since the last CCSG application in 1998, the PRMS has been significantly re-organized, enhanced, and expanded to provide a more rigorous scientific review of proposed clinical trials;to enhance and ensure appropriate statistical input during the review of clinical trials;to provide a comprehensive process for prioritization of clinical trials, and in particular, to allocate YCC resources to support investigator-initiated clinical trials;to ensure timely scientific monitoring of activated trials;and to enforce closure of poorly accruing trials. A new YCC Office of Protocol Review and Monitoring (OPRM) was created to provide and unify administrative support to the three PRMS Committees. A senior physician, Dr. Mario Sznol, with extensive experience in conducting and monitoring clinical research was recruited to provide medical leadership of the OPRM and to chair the PRC and QUACS. To complement physician leadership in this office, an experienced senior clinical research professional, Susan Anderson R.N., was appointed to be Operations Director of the OPRM. The OPRM supports the activities of the CRSC, PRC and QUACS Committees;maintains a tracking database for protocol reviews and approval, safety data submission, annual review submissions, and compliance audits;generates minutes for the CRSC, PRC and QUACS meetings;maintains a protocol priority list;tracks and files correspondence with investigators;contains the auditing function of the YCC, and conducts a rigorous training program for the clinical research staff in managing clinical trials and complying with regulatory requirements. A major initiative of the OPRM was to expand the membership and expertise of the PRC and to incorporate and establish a robust process for statistical input and review of trial. Future plans include recruitment and training of new PRC members, as well as training of fellows and junior faculty in methods of clinical research and review of clinical research.
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