Our goal is to provide a database system for the management of human subjects research that facilitates and supports our investigators while providing the necessary regulatory checkpoints in a complex environment with shared data systems and resources. We hope to move from our existing Access database for human research studies to an application suite that can be primed in concert with the development of the application materials. The system we envision will allow our research teams to build application packages on-line, drawing certain data points from the secure database. This will provide increased accuracy, flag investigator omissions, identify appropriate paperwork and remind users of specific submission requirements for the action indicated. It will also allow researchers and staff to verify project status on-line whenever necessary and will free staff to work on data analysis, rather than input to minimize the errors inherent in duplicative data entry. Our enhanced system will allow data transfer between our site and the University-based IRB, as well as providing limited secure access to our researchers and their staff? The system will also provide opportuities for more timely notification of IRB actions, allow increased identification of issues for QAI activities and encourage identification of changing staff to further protect the human subjects who participate in research.
