Protocol Review and Monitoring System

PROJECT SUMMARY – Protocol Review and Monitoring System The goal of the Abramson Cancer Center (ACC) Protocol Review and Monitoring System (PRMS) is to ensure scientific merit, priorities, and progress of cancer-related protocols. The ACC PRMS utilizes a first-stage review of protocols within disease- and discipline-focused Clinical Research Units (CRUs) and second-stage review by the adult and pediatric scientific protocol committees [Clinical Trials Scientific Review and Monitoring Committee (CTSRMC) and Pediatric Protocol Review and Monitoring Committee (PPRC)], respectively. The PPRC is based at Children’s Hospital of Philadelphia (CHOP) and oversees pediatric cancer protocols in accordance with the same ACC review guidelines and reports to the parent CTSRMC. These functions are coordinated by Dr. Roger Cohen, the Associate Director for Clinical Research, and Dr. Victoria Sallée, the Director of the ACC Department of Operations, Compliance and Monitoring (DOCM) – each of whom reports to and meets regularly with ACC Director Dr. Robert Vonderheide. The CTSRMC and the ACC Director have full authority to terminate any cancer trial at Penn or CHOP. Both the University of Pennsylvania and the CHOP Internal Review Boards rely on CTSRMC/PPRC for scientific review of cancer clinical protocols and require CTSRMC/PPRC approval prior to final IRB approval. CTSRMC/PPRC efforts do not duplicate functions of IRB, Data Safety Monitoring, or central NCI review bodies. At the time of the last CCSG review, our PRMS was deemed “Acceptable.” In the current funding period, enhancements to PRMS include further operationalizing our longstanding “first-stage” protocol review, following the guidance of the new CCSG FOA, as well as decreasing protocol activation times by 50% (such that the average time-to-activation is now 88 business days). The latter was accomplished by developing improved tools for data tracking and reporting, implementing sponsor Master Agreements to minimize budget and contract issues, increasing utilization of CIRB and commercial IRBs, and instituting reciprocity agreements with other peer PRMS committees. Specific Aims for PRMS are: (1) Support a first-stage review of clinical protocols at the disease- or discipline-level via our specialized CRUs; (2) Provide a second-stage scientific, statistical and feasibility review via CTSRMC/PPRC, which holds sole authority for approval of cancer clinical protocols, and (3) Provide continuing review by CTSRMC/PPRC of open protocols, including assessment of accrual, safety data, and scientific relevance, with authority to close trials for deficient accrual, unacceptable safety or scientific deficiencies.