PROTOCOL REVIEW AND MONITORING SYSTEM

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To help ensure the highest level of patient safety and research quality, the Cancer Therapy and Research Center (CTRC) at The University of Texas Health Science Center at San Antonio (UTHSCSA) Protocol Review Committee (PRC) is charged with the responsibility for internal oversight of the scientific and research aspects of all cancer clinical trials at the CTRC at UTHSCSA. The PRC helps to ensure that the Cancer Center's Shared Resources are engaged appropriately to facilitate the best possible study conduct and to maximize the overall scientific productivity of the Cancer Center. The primary PRC function is to review all studies for scienfific merit, to ensure prioritizafion of protocols according to P30 scienfific priorifies, and to monitor study progress for all cancer-related prevenfion and therapeufic clinical research protocols. The Chair of the PRC reports to the P30 Deputy Director. The P30 Office of Research Administrafion (ORA) is a Cancer Center shared resource which provides support to the PRC. The funcfion of the PRC is complementary to that of the UTHSCSA Insfitufional Review Board (IRB), which focuses on the protecfion of human subjects. All stipulafions identified by the PRC must be resolved prior to IRB submission. PRC funcfions do not duplicate or overiap with the responsibilifies of the IRB, nor does the PRC perform either auditing or data and safety monitoring functions which are performed in the CTRC by the ORA and the Data Safety and Monitoring Committee (DSMC) respecfively. The PRC is responsible for pre-acfivation and study continuafion activities related to scientific areas of research. All cancer-related studies involving the use of human subjects require the initial approval of this PRC prior to submission to the UTHSCSA IRB. The PRC has the authority to open protocols (with IRB approval) that demonstrate scientific merit and that meet the priorities of the P30. The PRC can close protocols that do not show sufficient scienfific progress or accrual. All studies, at time of inifial review are assigned a priority of audit level score (PALS) in a joint process between the PRC and DSMC. The Data Safety Officer (DSO), who is a member of both the PRC and DSMC, coordinates this process. A study PALS is then entered into the IDEAS database by the DSO. This score is used to determine the trial's overall likelihood of being audited by the DSO and the audit team. Approval of a protocol by PRC is a fundamental requirement, as is IRB approval, to allow performance of a cancer-related protocol by CTRC at UTHSCSA members within the affiliated institutions of the CTRC at UTHSCSA.