Web-Based System for Research Protocol Submission

University Of Virginia Charlottesville, Charlottesville VA

Investigators

Abstract

The University of Virginia has a PC-based system for human subjects protocol preparation, and the human subjects IRBs have robust database systems for tracking research protocols. During the first year of HSREP funding we have developed and are implementing a web-based system for research proposal entry, submission, circulation, review, storage and tracking. This system allows data to be transferred directly into our existing IRB databases. When fully implemented later this year, this new system will interconnect the activities of our two human subjects committees to other important institutional review committees: Radiation Safety; Institutional Bio-safety Committee; the General Clinical Research Center; and the Clinical Trials Office. We outlined expansion plans in our original application, and propose to use this additional funding to implement those plans, to extend our system to permit integration with the activities of the Cancer Center Proposal Review Committee, the Health System Material Support Services Office, the UVA Health System Library, and the Privacy Board. Though not a portion of our original application, we have also modified our database system to permit web-based entry of Adverse Event, which will replace our current, paper-based system for reporting which requires both that the paper forms are completed, and later manual data entry into the IRB database. The first AE was reported with this new system this week (July 6, 2003), and we will continue implementation of this system during the next year. We will try to reach small institutions by annoucements and demonstrations at local, regional and national meetings of the Society for Research Administration, International.