A Web-based protocol tracking management system for clinical research

Clinical research approval processes are complex since they involve human subject welfare as well as regulatory and ethical concerns. Typically, clinical research institutions have an elaborate established review process; the labor-intensive and time-consuming nature of this process can result in approval delays thus significantly impacting the biomedical research. This paper describes the development of a Web-based information system designed to make the process of protocol approval more efficient, organized, and accurate. The system enables the principal investigators (Pis) to initiate, track and manage clinical studies, monitor review processes, view status changes, and quickly respond to requests for additional information. In addition, it allows the protocol coordinators (PCs) to manage the entire Institutional Review Board (IRB) approval process.