The Protocol Review and Monitoring System (PRMS) oversees and ensures the prioritization, feasibility, scientific merit and progress of all clinical studies at the Cancer Therapy and Research Center (CTRC). The PRMS consists of three components that work in collaboration with one another to ensure that the right trials for the right population with the right resources open and accrue. This occurs via each of the committee's prioritization, feasibility, scientific review and progress in the selection and activation of all trials at CTRC. The PRMS evaluation process occurs prior to submission to submission to the UTHSCSA Institutional Review Board (IRB) and is required for IRB approval. The PRMS process is complementary to the IRB review and does not overlap or duplicate the responsibilities of the IRB. The IRB will not approve a protocol without the PRC's approval. Protocols are initially discussed in Clinical Disease Site Teams (CDST) teams where they receive priority scoring. Operations and Logistics Committee (O&L) where they are reviewed for feasibility, and then the Protocol Review Committee (PRC) where they receive data safety and monitoring, scientific and biostatistical reviews. After a study has opened to accrual, the PRC provides ongoing review to ensure adequate accrual and scientific progress. The PRC has the authority to close studies that have not progressed toward their intended scientific objectives.
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