Disqualification Proceedings
The next step is the initiation of disqualification proceedings. If a clinical investigator is permanently disqualified, they can no longer receive investigational drugs or function in a clinical investigator role.
Most clinical investigators are physicians, although that is not a requirement. If a person does not have the background, a medical monitor must provide the appropriate oversight. When physicians are disqualified, it does not directly impact their ability to practice medicine. FDA does not regulate the practice of medicine.
When FDA institutes disqualification proceedings, the Agency sends a consent agreement. If the investigator signs the agreement, they are fully disqualified, and FDA stops the proceedings.
A clinical investigator can choose not to sign and explain their side. If FDA and the investigator cannot agree, the Agency holds an administrative hearing to determine if the person should be disqualified.