Protocol Review and Monitoring System

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PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) at the Sylvester Comprehensive Cancer Center (Sylvester) oversees all cancer-related clinical and population science research conducted at the University of Miami. The main aims of the PRMS are to 1) provide timely review of the scientific merit of all cancer research studies; 2) ensure prioritization of cancer research studies according to Sylvester’s strategic plan, mission, and vision, including programmatic alignment and catchment area relevance; and 3) monitor the scientific progress of all cancer research studies. PRMS functions are accomplished by a two-stage rigorous review process. First, the Site Disease Groups (SDG) assess scientific and clinical value, patient availability, and priority within the existing research portfolio. Second, studies are reviewed by the Protocol Review and Monitoring Committee (PRMC) composed of reviewers with the depth and breadth of expertise necessary to conduct a critical and fair review of all protocols. In 2017, Sylvester subdivided the PRMC, creating a subcommittee for population science studies (PRMC-PS), composed of faculty with expertise in population science, biobehavioral, and epidemiologic studies and a subcommittee for medical studies (PRMC-M), composed of faculty experienced in clinical, translational, and biological studies. Both subcommittees include members from the Biostatistics and Bioinformatics Shared Resource and members with basic science expertise, and they operate under the same standard operating procedures. PRMC scientific review takes into account the specific rationale, study design, availability of adequate numbers of patients or subjects, presence of any competing studies, and robustness of biostatistical design, assuring internal oversight of the scientific merit of all cancer studies. The functions of PRMC complement, rather than overlap or duplicate, the Institutional Review Board (IRB), which is responsible for the protection of human subjects. Further, the PRMC does not perform any auditing or data and safety monitoring functions. The PRMC does not duplicate traditional peer review for studies supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s, and P50s) or approved by the NCI’s Cancer Therapy Evaluation Program. These protocols receive an expedited review for the purposes of prioritization. All studies are reviewed annually to evaluate scientific progress and continuing clinical and scientific relevance and importance; accruals are monitored every six months to ensure the study’s scientific design and that accrual is proceeding sufficiently to support the overall objectives of the study. Sylvester’s PRMC is administrated by the Research Committees Support Unit staff within Clinical Research Services. The PRMC has the final authority to close cancer studies not meeting scientific or accrual goals. Having a robust PRMS, which includes both the SDG and the PRMC review processes, is critical to ensure the highest quality cancer and cancer-related research is conducted by Sylvester investigators.