The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit and progress of all clinical studies at the Yale Cancer Center (YCC). The PRMS evaluation process occurs prior to submission to the Yale University institutional review board (known as the Human Investigation Committee or HIC) 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. There are two major committees of the PRMS that provide for clinical research review and oversight: the Clinical Research Steering Committee (SC), and the Protocol Review Committee (PRC). Although each Committee has a unique role, when combined these are aligned to ensure that research concepts and protocols move through the system in a timely fashion, receive high-quality peer review and monitoring, and that the research protocol is consistent with YCC clinical research priorities. Proposed protocols are initially discussed in disease teams and then presented to the SC where they are assessed for feasibility and consistency with overall YCC goals. After receiving SC approval the study then proceeds to the PRO for full scientific and biostatistical review, priority scoring and assessment of the data and safety monitoring plan. After approval the PRMS provides ongoing review to ensure adequate accrual, scientific progress and continued consistency with overall YCC goals. The SC conducts reviews of each disease team portfolio at six month intervals to assess progress, rates of accrual and continued consistency with the priorities of the YCC. The SC then makes recommendations for closure to the PRC if studies are not progressing towards the scientific objectives. The PRC has the authority to close studies. In Fiscal Year 2012, a total of 94 new protocols were evaluated by the PRMS for merit, and 201 protocols were monitored for scientific progress.
Promotes high quality scientific investigations consistent with the overall mission of the YCC that can be completed in a timely manner in order to improve treatments for cancer patients. The PRMS serves as a centralized review system to encourage creativity, collaborations, and well designed studies that will advance understanding and knowledge of cancer etiology, treatments and support services for patients.
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