Protocol Review and Monitoring System

PRMS PROJECT SUMMARY/ABSTRACT The goal of the Protocol Review and Monitoring System (PRMS) at the Holden Comprehensive Cancer Center (HCCC) is to ensure the highest scientific quality of clinical oncology research is conducted at the HCCC. A two-step review process is used. Trial concepts are first reviewed by the disease-specific Multidisciplinary Oncology Groups (MOGs) to determine enthusiasm for the proposed science, potential impact of the results and whether the resources and patient population are adequate to complete the proposed studies. The Trial Resource Evaluation Committee (TREC) provides input into whether the institutional resources are available to support the trial. Once a protocol is approved by the MOG and has TREC endorsement, it is fully developed and reviewed by the Protocol Review and Monitoring Committee (PRMC). The PRMC approves, rejects or defers the protocol for further development. Studies which have already undergone rigorous peer review including NCI-approved NCTN studies and studies approved by other NCI-designated cancer centers with an acceptable PRMS, are reviewed administratively by the PRMC Chair. PRMC approval is required before IRB review. The PRMC also monitors accrual to ongoing clinical trials. The PRMC closes protocols that do not demonstrate scientific progress or that are no longer addressing a scientifically valid question.