The Clinical Protocol Scientific Review and Monitoring System (CPSRMS) of the Robert H. LurieComprehensive Cancer Center (Cancer Center) is composed of several key committees including theClinical 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 andongoing clinical research protocols for scientific merit and institutional priority. This is required for all studiesthat have not received review and approval from an NCI-approved external peer review group. TheCPSRMC is a multidisciplinary committee that consists of a core group providing the necessary expertise inthe principal disciplines of clinical oncology with additional representation from Biostatistics, LaboratoryScience, Pharmacy, and Nursing. The CPSRMC is directly responsible for: 1) reviewing new clinical trials toensure that they are scientifically sound, 2) ensuring study priority has been assigned appropriately by thestudy Principal Investigator, 3) confirming that the clinical trials are relevant to the goals of the CancerCenter, 4) reviewing for adequacy of data and safety monitoring plans for each new protocol, 5) reviewingand 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 delegatesresponsibility for data and safety monitoring of clinical trials to the DMC and Audit Committee, whoseactivities are described in more detail in section 12.0, Data and Safety Monitoring.
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