US FDA Clinical Investigator Disqualification Proceedings

The FDA regulates clinical investigators who conduct studies intended to provide evidence on the safety and effectiveness of investigational medical products. Clinical investigators must follow applicable statutes and regulations to ensure the integrity of clinical data and, for studies involving human subjects, to protect their rights, safety, and welfare.

If the FDA determines that a clinical investigator has violated these requirements — such as through data falsification or non-compliance — it may initiate a disqualification proceeding.

This dataset lists investigators who have been subject to an administrative clinical investigator disqualification action, and indicates the current status of that action.