Tennessee Code 63-6-309 – Reporting of adverse events
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Terms Used In Tennessee Code 63-6-309
- Adverse event: means any untoward medical occurrence associated with the use of an investigational drug, biological product, or device in humans, regardless if drug-related. See Tennessee Code 63-6-302
If a patient suffers an adverse event associated with the use of an investigational drug, biological product, or device, the patient’s physician shall report the adverse event to the manufacturer of the investigational drug, biological product, or device