Informatics Director Center for Neuroscience and Regenerative Medicine, HJF Rockville, Maryland
Abstract Text: Clinical trials in Traumatic Brain Injury research provides a robust opportunity for the discovery of effective treatments. Regulatory compliance, real-time access to protocol progress, deviations and study personnel is critical. Currently, regulatory compliance uses physical documents (paper) or multiple-siloed systems, and this is a tremendous challenge for version tracking, access control and management of multi-site clinical trials. To improve efficiency and effectiveness, we present a collection of digitized tools to support regulatory compliance within an established informatics system. We demonstrate digitized regulatory components to include: Adverse event logs, protocol deviation log, training logs, electronic binder, audit trails, study monitoring logs, training records management, electronic consenting, electronic signature collection, and protocol document management; within our CNRM Collection Access Sharing and Analytics (CASA) platform that was developed explicitly to support military TBI research. The availability and accessibility of digitized regulatory compliance tools have helped reduce the cost for military treatment facilities and researchers pertaining to the administrative burden for tracking and curating these documents. In addition, efficiencies have been gained through the immediate access, search, and sorting of study documents and the reduction in physical records. Furthermore, the digital regulatory compliance tools have also provided access to non-DoD collaborators in an organized and meaningful manner, and have helped to reduce costs and alleviate administrative burden. Lastly, these tools provide an explicit process for data regulatory compliance, monitoring, curation and sharing.
