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Category: Serious Adverse Event (SAE) Management

Serious Adverse Event (SAE) Management in Clinical Trials: Complete Guide

Posted on April 29, 2025 digi By digi No Comments on Serious Adverse Event (SAE) Management in Clinical Trials: Complete Guide

Serious Adverse Events (SAEs) include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, leads to persistent or significant disability, or causes a congenital anomaly. Effective SAE management ensures rapid identification, assessment, reporting, and mitigation of risks during clinical trials, protecting participants and maintaining study integrity.
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Safety Reporting and Pharmacovigilance, Serious Adverse Event (SAE) Management

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