CRAs and Adverse Event Resolution During Clinical Research Close Out Visits

Capturing Adverse Events (AEs) during a study and entering them into Electronic Data Capture (EDC) system helps sponsors gain valuable information about the safety of their investigational products. Most coordinators are able to contribute to patient safety by correctly entering AEs and including relevant information such as start dates into the EDC. Unfortunately some coordinators forget to enter AE end dates until a monitor or data management issues queries about the status of open AEs.