Quality Improvement in Clinical Research: ESA Utilization to improve Patient Safety Monitoring, time management, and Research Compliance

Abstract

AbstractWe analyzed the capabilities of Electronic Signature Administrators (ESA) in reporting adverse and serious adverse events (AE/SAE) in clinical trials to improve Principal Investigator (PI) oversight. The current and most conventional way to sing on AE/SAE reports, by wet ink paper signatures, faces long report completion times, miscommunications, and a high rate of error that can put the study and the patient at risk. We demonstrate here that ESAs can easily take over this task, speeding up the process and enhancing patient’s safety and research compliance. Our results show that the average of 31 days to obtain wet-signatures on AE/SAE reports is reduced to merely 3 days after the implementation of ESA. We also found that research professionals spend more than half an hour in commuting each time they need to get PI signatures, while this time is zero if ESAs are used. Finally, an anonymous survey distributed to coordinators shows that ESAs can be well received when implemented since 86% have used an ESA and are satisfied with it or are interested in using it, while only 14% of the participants are either not interested or not satisfied.