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

We 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.

SoTL and the Institutional Review Board: Considerations before navigating the application process for classroom research in higher education

One of the more challenging areas of Scholarship of Teaching and Learning (SoTL) research can be navigating the components of human subjects research protections implemented by the Institutional Review Board (IRB). The authors of this article, a faculty developer and a current and former research compliance coordinator, discuss the history of IRB in relation to SoTL research and explicate some of the foundational components of IRB protocols for SoTL projects. In particular, the authors explore what constitutes “research” for SoTL projects, explain the different IRB types of review, and offer some sample SoTL projects with respect to their IRB implications.