Cancer Clinical Trials Review Committees

During the Full Committee Review process, reviewers utilize a review form to document key elements of the study; answer questions with respect to study rationale, scientific merit, quality and adequacy of the design, and eligibility criteria; and confirm an appropriate data and safety monitoring plan, data analysis plan, expected accrual rates, completion feasibility, and risk profile of the study. The PRMC assigns protocol risk to institutional trials (low, moderate, and high) based on the risk assignment criteria in the Center’s Data and Safety Monitoring Plan. The PRMC also reviews the documentation provided by the Disease Research Group to ensure there are no competing studies and the study was highly valued.

Expedited Reviews are conducted by the PRMC Chair and/or Vice Chair and are generally limited to those studies identified as eligible for Expedited Review. For studies meeting the criteria, the PRMC Chair and/or the Vice Chair reviews all submission materials and gives a rapid expedited review, assuring that conflicts with current studies do not exist, resources appear to be in place to implement and complete the study, and an appropriate data and safety monitoring plan is in place. If no substantive issues are identified during the review, the PRMC Coordinator will then generate an approval letter which is then routed via email through OnCore to the PI. Expedited reviews are completed within seven business days of receipt. A summary report of all studies that received expedited review since the last PRMC Full Committee is included in the agenda and noted in the minutes for each PRMC meeting.

The following studies are exempt from PRMC review: single-use IND, retrospective studies, registries and biorepositories and questionnaires that do not test interventions.