APPARATUS AND METHOD FOR INTEGRATED MANAGEMENT OF CLINICAL TRIALS AND STUDIES AT AN IRB

摘要

The apparatus and methods of the present invention implement a computer-based system and procedure for the efficient and effective operation of one or more clinical trials using an IRB. The various methods are deployed against the backdrop of an Internet-based Software As A Service (SaaS) platform, allowing access to the system by all relevant participants. Each authorized participant in the clinical trial can have a customized and customizable view of the clinical trial and interact with the other participants electronically. The various documents required for completion of the clinical trial or study, as well as the various compliance documents needed to satisfy regulatory agencies are all available for review via the Internet. By utilizing the methods and system of the present invention, greater protection is offered for the human subjects of the clinical trials. Further, the sponsors, investigators, and the study participants can experience increased productivity. Finally, FDA mandated information can be more readily tracked and, accordingly, compliance with FDA guidelines can be enhanced.