Quality Improvement in Clinical Research: ESA Utilization to improve Patient Safety Monitoring, time management, and Research Compliance.
Del Pino, M.; Bonmati, A.; Mendoza, P.
Show abstract
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 patients 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.
Matching journals
The top 7 journals account for 50% of the predicted probability mass.
Similar papers in this journal
- An interactive retrieval system for clinical trial studies with context-dependent protocol elements 96%
- REPLICCAR II Study: Data Quality Audit in the Paulista Cardiovascular Surgery Registry 94%
- Common misconceptions held by health researchers when interpreting linear regression assumptions, a cross-sectional study 94%
Similar papers in this journal
- Open Science Practices Among Authors Published in Complementary, Alternative, and Integrative Medicine Journals: An International, Cross-Sectional Survey 94%
- The PBL teaching method in Neurology Education in the Traditional Chinese Medicine undergraduate students: An Observational Study 92%
- SGCI (Smartwatch Gait Coordination Index): New Measure for Human Gait Utilizing Smartwatch Sensor 89%
Similar papers in this journal
- Supporting Reanalysis and Reuse of Clinical Trial Data: A Case Study 93%
- Number of Interventional Clinical Trials Registered per Million Population per Country Worldwide 92%
- Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial 91%
Similar papers in this journal
- Transformative potential of Large Language Models in data mining on Electronic Health Records. 94%
- Evaluating the impact on clinical task efficiency of a natural language processing algorithm for searching medical documents: Prospective crossover study 94%
- Assessment of Accuracy and Safety of LabTest Checker (LTC-AI) 94%
"Similar papers" are the closest papers from that journal in the model's embedding space. They show what the match is built on, but the ranking comes mostly from a classifier over the whole training set, not from these examples alone.