Protocol Review and Monitoring System

Mayo Clinic Rochester, Rochester MN

Investigators

Linked publications, trials & patents

Abstract

The Mayo Clinic Cancer Center (MCCC) oversees the scientific aspects of cancer clinical trials conducted at Mayo Clinic through the Center's Protocol Review and Monitoring System (PRMS). Responsibilities of the PRMS are independent and non-overlapping with those of the Mayo IRB and those with responsibilities specific to Data and Safety Monitoring activities. The focus of the PRMS is on scientific merit, priorities, and progress of the clinical research protocols conducted at the MCCC. Due to the volume of studies and significant differences in study population, scientific review is accomplished through one of the Center's two scientific review committees, the Scientific Review Committee (SRC) A and B. The SRC-A reviews all interventional hematologic malignancy studies; the SRC-B reviews all other interventional studies. To ensure consistency across committees, each committee adheres to the same policies and procedures and has ultimate responsibility for the approval/disapproval of each study as well as the final decision concerning prioritization. Dr. Henry Pitot provides overall leadership and expertise to the PRMS. The SRC committees are chaired by Drs. Thomas Witzig (SRC-A: interventional hematologic malignancy studies) and Timothy Hobday (SRC-B: all other interventional studies). The scientific review committees have the authority to approve/defer/disapprove protocols and subsequent amendments and modifications that meet the scientific merit and scientific priorities of the MCCC. In addition, these committees have the authority to close any protocol due to insufficient or poor accrual.