In clinical trials, who typically provides the primary oversight of the investigational product?

The principal investigator (PI) is the individual who holds primary responsibility for the oversight of the investigational product in clinical trials. This person is typically a qualified physician or researcher who leads the clinical trial at a specific site. The PI ensures that the study is conducted in compliance with regulatory guidelines, ethical standards, and the study protocol. They are responsible for overseeing the safety and welfare of participants, managing the administration of the investigational product, and ensuring accurate data collection.

The principal investigator plays a critical role in monitoring the use of the investigational product, ensuring that it is administered correctly and that any adverse events are reported and addressed promptly. They also serve as the primary point of contact for regulatory authorities and institutional review boards. This level of involvement and authority is essential for maintaining the integrity of the clinical trial and safeguarding participant safety.