title: An automated standardized system for managing adverse events in clinical research networks.
abstract: Multi-site clinical protocols and clinical research networks require tools to manage and monitor adverse events (AEs). To be successful, these tools must be designed to comply with applicable regulatory requirements, reflect current data standards, international directives and advances in pharmacovigilance, and be convenient and adaptable to multiple needs. We describe an Adverse Event Data Management System (AEDAMS) that is used across multiple study designs in the various clinical research networks and multi-site studies for which we provide data and technological support. Investigators enter AE data using a standardized and structured web-based data collection form. The automated AEDAMS forwards the AE information to individuals in designated roles (investigators, sponsors, Data Safety and Monitoring Boards) and manages subsequent communications in real time, as the entire reporting, review and notification is done by automatically generated emails. The system was designed to adhere to timelines and data requirements in compliance with Good Clinical Practice (International Conference on Harmonisation E6) reporting standards and US federal regulations, and can be configured to support AE management for many types of study designs and adhere to various domestic or international reporting requirements. This tool allows AEs to be collected in a standard way by multiple distributed users, facilitates accurate and timely AE reporting and reviews, and allows the centralized management of AEs. Our design justification and experience with the system are described.
authors.affiliation: University of South Florida College of Medicine, Tampa, Florida 33612, USA. richesrl@epi.usf.edu
authors.forename: Rachel L
authors.initials: RL
authors.lastname: Richesson
authors.forename: Jamie F
authors.initials: JF
authors.lastname: Malloy
authors.forename: Kathleen
authors.initials: K
authors.lastname: Paulus
authors.forename: David
authors.initials: D
authors.lastname: Cuthbertson
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Krischer