Protocol Review and Monitoring System

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY/ABSTRACT The UC Davis Comprehensive Cancer Center (UCDCCC) Protocol Review and Monitoring System (PRMS) provides a mechanism for ensuring internal oversight of the scientific and research aspects of cancer clinical trials and for assuring that the UCDCCC's clinical resources are optimally engaged. The PRMS is intended to cover clinical research activity meeting the NCI definition of a clinical trial, as defined in the Data and Safety Monitoring Plan (DSMP). During the reporting period, the PRMS implemented several key processes to ensure UCDCCC is maintaining a robust clinical research portfolio. The PRMS is comprised of two key committees including the Disease Team Committees (DTCs) and the Scientific Review Committee (SRC). The DTCs and SRC are responsible for the rigorous review of clinical protocols through a sequential two-stage process. At UCDCCC, there are seven multidisciplinary, oncology focused DTCs including Breast, Gastrointestinal, Genitourinary, Hematological malignancies, Phase I, Pediatrics, and Thoracic. Using standardized review criteria, DTCs conduct the initial evaluation of a potential protocol for value, fit, and prioritization within the UCDCCC trial portfolio. A protocol must be endorsed by the DTCs before heading to the SRC. The SRC is the definitive independent authority that determines if a trial will be submitted to the Institutional Review Board (IRB) for subsequent activation. The SRC provides essential review elements for scientific merit, prioritization, resource allocation, and accrual monitoring. Once a trial is activated, an SRC sub-committee called the Protocol Accrual Monitoring Committee (PAMC) is responsible for regularly reviewing trial accruals and communicating with investigators. Based on PAMC findings, reminders are sent to investigators prior to SRC intervention, in order to allow corrective actions or clarifications of issues. Once PAMC makes a recommendation to close a trial due to poor or no accrual, the recommendation returns to SRC who has the final authority to close that trial.