CORE--PROTOCOL REVIEW AND MONITORING

Washington University, Saint Louis MO

Investigators

Linked publications & trials

Abstract

The primary goal of the Protocol Review and Monitoring Committee is to ensure that institutional and industry-initiated cancer research studies involving human subjects conducted within Washington University Medical Center are: (1) scientifically and statistically sound, (2) appropriately designed, (3) feasible for completion, and (4) if applicable, in compliance with NIH guidelines for clinical trials, including monitoring for accrual and undue toxicity. For the purposes of this committee, a cancer research study is defined as a formal research plan that: (1) is intended to evaluated an untested, unproven or unknown regimen or procedure for the screening, diagnosis, staging, treatment, support, outcome, prevention, control or characterization of human subjects in regard to cancer, or, or (2) compares standard to unproven regimens or procedures, and (3) requires the approval of the Human Studies Committee (HSC). The PRMC is responsible for: providing scientific peer-review for all investigator- and industry- initiated cancer research studies. reviewing all active cancer research studies for renewal/termination. reviewing accrual in all active cancer research studies. assessing protocol compliance in institutional research trials. assessing for accurate and adequate reporting of toxicities and adverse events. providing information about study design and execution.