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In clinical research, Serious Adverse Events (SAEs) are events that result in significant health consequences, such as death, hospitalization, or disability, while Adverse Events (AEs) encompass any undesirable experience associated with a treatment, regardless of severity. SAEs require immediate reporting to regulatory authorities and have stricter monitoring protocols due to their potential impact on patient safety. Understanding the distinction between AE and SAE is crucial for ensuring participant safety and compliance with regulatory requirements in clinical trials.

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