PROTOCOL REVIEW AND MONITORING SYSTEM - ABSTRACT The Protocol Review and Monitoring System (PRMS) serves a critical role in ensuring the execution of high-quality cancer-related clinical research within the University of Hawai‘i Cancer Center (UHCC) and its extensive network of community-based hospitals, health systems, and oncology providers, all operating within the UHCC-led clinical trials infrastructure. The PRMS review process has been designed in compliance with Cancer Center Support Grant (CCSG) guidelines to ensure all studies undergo rigorous review and monitoring. The PRMS review process consists of two distinct stages. The first-stage review is now done by Disease Site Working Groups (DSWGs) and before March 2023 by the Clinical Trials Office (CTO) Operations Committee. They conduct a comprehensive assessment of studies, focusing on scientific merit and alignment with UHCC’s portfolio requirements and priorities. Before the initiation of DSWGs, the CTO Operations Committee conducted the initial review and prioritization of studies. This committee then forwarded their recommendation to the PRMC for second-stage review. Between January 2018 and March 2023, the CTO Operations Committee reviewed 279 new studies, with 164 receiving recommendations for a second-stage review. The DSWG, initiated in March 2023, consists of ten discipline groups. They conduct the initial review and prioritize studies. Priority is assigned first to funded Investigator Initiated Trials (IITs), followed by national and industrial studies. Studies recommended for approval are subsequently routed for PRMC review. Since the introduction of DSWGs in March 2023 and through August 2023, 57 new protocols have been reviewed, with 20 already receiving recommendations for second-stage review. Some of the others are in progress. The CTO acts as the crucial communication channel between DSWGs and the PRMC. Additionally, it provides essential administrative support and logistical expertise. The Protocol Review and Monitoring Committee (PRMC), chaired by Jeffrey Berenberg, MD (reports to Naoto Ueno, MD, PhD, UHCC Director), conducts the second-stage review. The PRMC is responsible for an independent scientific evaluation and holds the exclusive authority to approve studies for activation. The PRMC serves as an independent scientific review committee with the ultimate authority to approve trials for activation and terminate studies that fail to demonstrate scientific progress. They conduct annual reviews of active protocols to monitor scientific progress and accruals, terminating studies when necessary. The PRMC’s functions are distinct from those of the Institutional Review Board (IRB) and do not duplicate their responsibilities. Between January 1, 2018, and December 31, 2022, the PRMC reviewed 164 new studies, approving 155 for activation. In addition, the PRMC conducted 305 annual reviews, resulting in the termination of 41 studies due to slow accrual. All PRMS activities ...