How is an adverse event defined in the context of medical research?

The definition of an adverse event in the context of medical research encompasses any undesirable experience associated with medical products, including drugs and devices. This comprehensive definition acknowledges that adverse events can encompass a wide range of experiences that may not be limited to just physical or psychological harms. By recognizing the broader scope of adverse events, it allows researchers and regulatory bodies to monitor and evaluate safety concerns more effectively.

This approach ensures that any negative reactions or experiences, regardless of severity or type, are recorded and assessed during a clinical trial or research study. This holistic perspective is crucial for understanding the full impact of medical products on subjects' health and well-being. The inclusion of various adverse experiences allows for better risk management, ultimately leading to safer medical practices and improved patient care.