The Clinical Protocol Scientific Review and Monitoring System (CPSRMS) of the Robert H. Lurie Comprehensive Cancer Center (Cancer Center) is composed of several key committees including the Clinical Protocol Scientific Review and Monitoring Committee (CPSRMC), Data Monitoring Committee (DMC), and the Audit Committee. The CPSRMC is charged with the responsibility of evaluating all new and ongoing clinical research protocols for scientific merit and institutional priority. This is required for all studies that have not received review and approval from an NCI-approved external peer review group. The CPSRMC is a multidisciplinary committee that consists of a core group providing the necessary expertise in the principal disciplines of clinical oncology with additional representation from Biostatistics, Laboratory Science, Pharmacy, and Nursing. The CPSRMC is directly responsible for: 1) reviewing new clinical trials to ensure that they are scientifically sound, 2) ensuring study priority has been assigned appropriately by the study Principal Investigator, 3) confirming that the clinical trials are relevant to the goals of the Cancer Center, 4) reviewing for adequacy of data and safety monitoring plans for each new protocol, 5) reviewing and approving all letters of intent prior to development of a local investigator-initiated clinical trial, and 6) reviewing and approving protocol amendments prior to IRB submission. The CPSRMS delegates responsibility for data and safety monitoring of clinical trials to the DMC and Audit Committee, whose activities are described in more detail in section 12.0, Data and Safety Monitoring.
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