PROTOCOL REVIEW AND MONITORING SYSTEM

$67,902P30FY2017CANIH

Medical University Of South Carolina, Charleston SC

Investigators

Linked publications & trials

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Abstract

The Hollings Cancer Center's (HCC) Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit, priority, value, and progress of all cancer clinical studies conducted at the Medical University of South Carolina (MUSC). The HCC Protocol Review Committee (PRC), appointed by the HCC Director and administratively supported by the HCC Clinical Trials Office (CTO), has the authority and charge to carry out this mandate. Additionally, the HCC Disease Focus Groups (DFGs) Interface with the PRC through their responsibility to only submit protocols for PRC review that have been thoroughly vetted by the DFGs with respect to study needs and priorities, feasibility, value-added to their trial portfolios, and competing trials. The DFGs also regularly monitor their trial accrual in parallel with the PRCs semi-annual accrual review of all HCC clinical trials. The primary goal of the PRC is to ensure that investigator-initiated and industry-sponsored cancer research studies involving human subjects conducted at MUSC are: 1) scientifically and statistically sound; 2) appropriately designed; 3) feasible for completion; 4) bringing added value to the HCC mission; 5) monitored regularly for accrual and scientific progress; and 6) In compliance with NIH guidelines for human studies.

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