| Sumario: | Significance & Background: In clinical trials, it is essential to document key elements during each subject's visit to ensure comprehensive data collection. Adverse event (AE) logs represent a critical element of a research study as they allow study investigators, sponsors, and government regulatory agencies to review the overall risks associated with the drug or device and assess the safety of the intervention. While many of these elements are recorded in the subject's electronic medical record (EMR) the aggregate information is often documented on a table outside of the EMR. This fragmentation creates challenges for both internal and external research teams. Enhancing Epic's AE modules could improve efficiency and data integration. Purpose: To evaluate whether the electronic Adverse Event module within the Epic (EMR) system effectively supports clinical research by enhancing the accuracy, efficiency, and quality of adverse event reporting. The module must be in a centrally accessible location for internal/external research personnel. It must use the Common Terminology Criteria for Adverse Event (CTCAE) Dictionary published by the U. S. Department of Health and Human Services. It must capture key data elements of adverse events. It must have a robust audit trail. Interventions: Limitations identified with the use of paper forms are different formats are utilized, legibility can be poor, updates and review can be delayed, audit trails and version control can be hard to follow and potentially a lack of space and funding required for long-term storage. Benefits of the Epic AE module include robust audit trail, legible, real-time access to allow for timely updates and review, key elements of adverse event reporting are captured, retention and storage of data within the EMR and study specific version of the CTCAE dictionary is employed. Results: After initial testing, updates were made for the module to be fully functional. The module was customized to allow investigators to record AE attributions for each drug. The outcomes and action taken fields were populated with choices from a drop-down menu. Discussion: The current Epic AE module meets the criteria of being centrally accessible, allows real-time access, captures the key elements of adverse event reporting, has the appropriate version of the CTCAE dictionary associated with each study and has a robust audit trail.
|
|---|