Leveraging electronic health record query to streamline adverse event reporting and protocol compliance

Abstract

Electronic medical records are increasingly being leveraged to improve the efficiency and effectiveness of clinical trials. Reporting safety data and adhering to follow-up schedules are two challenges faced by study centers conducting a large number of clinical trials led by a single principal investigator.The Lenox Hill Electrophysiology Research Department collaborated with Northwell Health's informatics department to develop a live query accessing both inpatient and outpatient data. To demonstrate the efficacy of this approach we compared the compliance rate of adverse event reporting and patient follow-up visits between a clinical trial run using this approach and a clinical trial conducted prior to use.We compared the number of out of window visits, missed visits, missed assessments, subject drop out and number of late reported adverse events between both studies. The trial run using the described query method had a marked reduction in these categories. Leveraging available informatics resources have allowed for improved efficiency, accurate adverse even reporting and improved follow-up scheduling.