With the proposed grant we will develop electronic tools to support two critical IRB functions - IRB application review and audit review. While the actual reviews will be conducted by IRB members and/or compliance office staff, we will employ the latest in computer technology to facilite the speed and accuracy of these processes. At present these functions are performed almost entirely by staff using traditional antiquated time-consuming methods involving mostly manual clerical labor. The automated system will employ electronically-based forms for assisting in the review process and for assisting in the audit review process. Both the electronic review and audit systems will be developed by the project. The electronic review system will allow IRB reviewers to download review forms to their own personal computers, document the completion of their review, and submit review information electronically to the IRB off.me over secure connections for consideration at the next IRB meeting. The IRB meeting room will be specially equipped with a wireless connection system that will allow the reviews to be projected on a screen via TabletPCs (one for the Chair and one each for the primary and secondary reviewers), which in tum will be controlled by the Panel Coordinator using a desktop computer. The IRB panel will then direct changes to the review form as necessary and the resulting document will be saved electronically on Lotus Notes databases (which will either be transferred electronically or accessed later by the Panel Coordinator for written communication with the PI). We view the development of this system as the first step toward eventual electronic protocol submission and review. The electronic audit system will be developed in parallel with the electronic review system on TabletPCs and electronic database systems. VCU's Administrative Information Technology Office will create the necessary databases, forms and programming that will be used for communicating IRB application assignments to reviewers, reviewing those applications, communicating the reviews to IRB members, allowing reviews to be seen and modified as necessary during IRB meetings, communicating IRB actions to investigators, etc. Outside consultants will be hired to prepare design documents, to map data flows between administrative staff, IRB members, and investigators, and to assist staff in developing reports and audit functionality.
