The goal of this project is to enhance and strengthen the human subjects protection program at the University of South Florida (USF) through the development and implementation of an electronic submission and tracking system for evaluating and coordinating adverse event (AE) reporting. Desirable outcomes include: o A Web-based electronic submission form will be created for the use of investigators to notify the Institutional Review Board (IRB) of an AE. o A database will be developed for capturing AE Report form contents directly from the Web-based submission form into an adverse events tracking database. o A statistical model will be created to correlate the information collected in the AE database with MedWatch reports and medical experts' ranking of adverse events' severity, such that a quantitative assessment of increases, decreases, or no changes in risk to human subjects participating in research. Information from the statistical model will be added to the AE Report and supporting documents for IRB assessment. o The resultant report will be made available via a secure Web site to the Authorized Institutional Official (Vice President for Research) and other appropriate university administrators, IRB Chair, board members, investigators, sponsors, and Data Safety and Monitoring Boards (DSMBs). By streamlining and quantifying key aspects of the qualitative AE assessment process, the IRB will be able to make rapid, reliable, real-time assessment of AEs. More importantly, the proposed enhancements will enable the IRB to take immediate action to protect human subjects from changes in research risks. USF will support the expansion of this project beyond AE Reporting to include other aspects of research compliance oversight such as new applications, continuing review, and changes in procedure. With these long-term objectives in mind, we have incorporated the most advanced, expandable server and programming software available on the market into this protocol. In addition, we will develop a training course to be used as a model for developing future continuing education programs for online submissions.
