Protocol Review and Monitoring Systems

The Indiana University Simon Comprehensive Cancer Center (IUSCCC) Protocol Review and Monitoring System (PRMS) is made up of the Scientific Review Committee (SRC) and the Protocol Progress Committee (PPC), which oversee and provide independent peer review of the scientific merit, feasibility, priority, and progress of all cancer-related research involving human subjects conducted across IUSCCC. PRMS functions are accomplished by a rigorous three-stage process conducted by Disease-Oriented Teams (DOTs), the SRC, and the PPC. The DOTs, comprised of a team leader and members, are responsible for the initial review of studies with regards to feasibility in relation to available resources, research value, fit within the team portfolio, and prioritization. They are also responsible for monitoring these studies for continued merit, accrual, and appropriate conduct. The SRC reviews all potential cancer-related studies across the DOTs and evaluates them for scientific quality, effective and rational trial design and endpoints, prioritization, feasibility, appropriate data and safety monitoring, and monitoring for ongoing accrual and trial progress. The PRMS, comprised of the SRC and PPC, complements the responsibilities of the Institutional Review Board (IRB) and the data and safety monitoring committees.