Protocol Review and Monitoring System (PRMS)

Roswell Park Cancer Institute Corp, Buffalo NY

Investigators

Linked publications, trials & patents

Abstract

The Roswell Park Cancer Institute (RPCI) Protocol Review and Monitoring System is under the direct responsibility of Alex A. Adjei MD, PhD, Associate Director for Clinical Research with administrative support provided by Joyce Yasko PhD, Administrative Director, and Laurie Musial RN, MS, CCRP, Administrative Co-Director. Dr. Yasko and Ms. Musial oversee daily operations of the PRMS components, which include the Clinical Research Feasibility and Prioritization Committee (CRPC), the Scientific Review Committee (SRC), the Response Review Committee (RRC), the Phase I Committee, and the Clinical Research Management System (CRMS). The CRPC was established in 2007 to enhance the process of study protocol development; to ensure that only high quality clinical research studies are performed, to optimize collaboration among RPCI investigators and to monitor RPCI resource utilization. All RPCI sponsored clinical research studies utilizing RPCI resources are reviewed at the concept stage (Investigator-Initiated) or study protocol stage (Industry Sponsored or National Cooperative Groups) to ensure a cohesive institution-wide clinical research program. CRPC approval must be obtained before a study is allowed to progress to SRC review and approval. All RPCI sponsored clinical research studies are reviewed by the SRC prior to submission to the IRB. The scope of SRC responsibilities includes review and approval or disapproval of new and ongoing clinical research studies, study amendments, monitoring reports, and corrective actions of non-accruing and slow accruing studies. The SRC reviews new studies to ensure that scientific content and study design are appropriate, that they are prioritized based on scientific resources, they are appropriately prioritized, and that there is statistical oversight in place. The RRC is charged with reviewing radiological responses of intervention studies and the Phase I Committee is charged with reviewing all aspects of institutional Phase I studies, respectively. The RRC reports outcomes to the SRC and the Data and Safety Monitoring Board, while the Phase I Committee reports findings to the IRB. The CRMS is the electronic database developed to provide management, capture and track all RPCI clinical research studies and their activity. The CRMS electronically monitors RPCI studies from initial submission, through the SRC and IRB review and approval process, through the study implementation process, until study termination. The Clinical and Protocol Data Management Services (CPDM) uses CRMS to manage over 2000 studies.