UNIT 9: Safety Management and Pharmacovigilance (Clinical Phase)
This unit explains how safety is monitored, assessed, and reported during the clinical phase of drug development to protect trial subjects. It focuses on adverse event management, regulatory reporting requirements, and ongoing risk–benefit evaluation throughout clinical trials.
Safety monitoring is a critical component of clinical research and ensures early detection, evaluation, and management of risks associated with investigational products. Continuous safety oversight helps maintain an acceptable balance between potential benefits and risks for trial subjects.
Key Points
Protects subject safety and well-being
Identifies emerging safety signals
Supports informed risk–benefit decisions
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