07 Jun UW Health, UW School of Medicine and Public Health to launch clinical trial review process

UW Health and the UW School of Medicine and Public Health (SMPH) have convened a new committee to help centralize and streamline the clinical trials review process at UW–Madison.

The cross-departmental, cross-functional committee, referred to as the UW Health/SMPH Research Operations Committee (UROC), will provide a single intake and operational feasibility review process for all non-oncology clinical trial requests prior to IRB submission. Oncology-focused trials will still be required to go through the UW Carbone Cancer Center’s Protocol Review and Monitoring Committee (PRMC). The UROC review process will begin with a proposal submission to the committee, which will meet bi-weekly, and will conclude with a recommendation letter and feasibility assessment.

“UROC is a collaborative effort to improve and support clinical trials operations at UW,” said Betsy Nugent, chief clinical research officer, UW Health and SMPH. “This committee will provide the opportunity to accelerate the launch of our clinical trials, as well as help ensure their success.”

All proposed trials that will utilize UW Health services, personnel, facilities and/or engage with UW Health patients need to undergo committee review to assess the operational feasibility of the study. Factors to be considered by the committee include but are not limited to: alignment with UW Health/SMPH clinical research priorities; impact on related infrastructure, ancillary services and care teams; availability of targeted patient populations and adequate recruitment plans; number of studies competing for similar patient populations and sufficient budget and funding sources to complete the trial.

The first protocol submission deadline, under UROC, is July 17. The committee plans to meet on July 26. For more information, please visit https://uwclinicaltrials.org/uroc/