Disqualification of a Clinical Investigator [21 CFR 312.70]
If the FDA obtains information indicating that the SI or an investigator has repeatedly or deliberately failed to comply with the regulations or has submitted false information to the FDA in any required report, the following will occur:
- The FDA will notify the investigator in writing of the complaint.
- The investigator will be given an opportunity to explain the matter in writing, or in an informal conference.
- If the investigator’s explanation is not accepted, the investigator will be given an opportunity for a regulatory hearing to determine if the investigator is entitled to receive investigational new drugs.
- If, after evaluating all available information, the Commissioner of the FDA determines that the investigator has repeatedly or deliberately failed to comply with the requirements or has deliberately or repeatedly submitted false information to the FDA or the sponsor, the Commissioner will notify the investigator, the sponsor of any investigation that the investigator has participated in, and the reviewing IRBs that the investigator is not entitled to receive investigational drugs. The notification will provide a statement of basis for such determination.
- Each application or submission to the FDA containing data reported by the investigator who has been determined to be ineligible to receive investigational drugs is subject to examination to determine whether the investigator has submitted unreliable data that are essential to the continuation of the investigation, the approval of any marketing application, or to the continued marketing of an FDA-regulated product.
- If, after eliminating unreliable data submitted by the investigator, the Commissioner determines that it is not reasonably safe to continue the investigation, the Commissioner will notify the sponsor who shall have an opportunity for a regulatory hearing.
- If a danger to the public health exists, however, the Commissioner shall terminate the IND immediately and notify the sponsor and the reviewing IRBs of the termination. The sponsor will have an opportunity for a regulatory hearing before the FDA to determine whether the IND should be reinstated.
- If, after eliminating unreliable data submitted by the investigator, the Commissioner determines that the continued approval of the drug product cannot be justified, the Commissioner will proceed to withdraw approval of the drug product in accordance with the applicable provisions of the relevant statutes.
- An investigator who has been determined to be ineligible to receive investigational drugs may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ investigational drugs and will conduct clinical investigations regulated by the FDA solely in compliance with the regulations.