Health Informatics Centre (HIC), University of Dundee Live Lounge

Improving Efficiency without Risk To Safety - Web-based Pharmacovigilance Tracker (PVT) Software Tool for Clinical Trials – Health Informatics Centre, University of Dundee

Accurate reporting of Serious Adverse Events (SAEs) in clinical trials is crucial for promptly detecting potential risks to patient safety. Conventional adverse event recording methods, such as paper-based or partially digitalised systems such as emails, can be onerous. These methods can be prone to transcription errors and consume valuable staffing time, which may result in breaches in meeting reporting deadlines to regulatory bodies.A fully integrated web-based Pharmacovigilance (PV) Tracker was developed at the University of Dundee designed to monitor, track, and classify SAEs occurring within clinical trials including Serious Adverse Reactions, Suspected Unexpected Serious Adverse Reactions (SUSARs) and non-immediately reportable events.