Clinical Event Adjudication (CEA) concerns unbiased classification, so-called adjudication of clinical events, and is becoming increasingly important and common in today's clinical trials. Centralized and standardized classification of patient events results in higher quality and greater safety when assessing reported events.
For every clinical event, relevant medical record actions (e.g. discharge summaries, ECG, and lab reports) are compiled together to create an electronic "event package" which is subsequently reviewed by specialist physicians. Each single event is reviewed separately by two physicians who classify the event in accordance with predefined study-specific criteria.
Extensive experience, capacity and well-established routines enable UCR to assist customers in meeting the requirements of the authorities. Our electronic, web-based system makes the process user-friendly, efficient and secure for small and large clinical studies. Since 2007, UCR has performed more than 50,000 adjudications.