Protocol Review and Monitoring System

Protocol Review and Monitoring System: Summary/Abstract The goal of the HDFCCC Protocol Review and Monitoring System (PRMS) is to ensure rigorous scientific review and monitoring of all clinical research undertaken in the HDFCCC. This is accomplished through a two- stage process, first by disease-focused and discipline-focused site committees that undertake initial scientific review of protocols, assessment of feasibility and projected accrual rates, and study prioritization; and then by the Protocol Review and Monitoring Committee (PRMC) that reviews scientific rationale, study design, expected accrual rates, adequacy of biostatistical input, feasibility of study completion within an appropriate time period, and ongoing review of scientific progress, including scientific relevance and accrual rates. As part of its review process, the PRMC undertakes prioritization of all clinical research studies across the HDFCCC. This provides a touchpoint to assess alignment of clinical trials with the Center-wide strategic plan and priorities, and an opportunity to prioritize research related to the cancer burden in the catchment area, high priority cancers, and underserved or marginalized communities.