An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Tracking all AEs is important as this:
- Helps timely mitigation of serious harm to study participants
- Decides whether a clinical study needs to be revised or terminated
- Develops accurate drug toxicity profiles
- Ensures compliance with regulatory requirements.
