FDA’s field staff conduct on-site inspections of clinical investigators involved in the investigation of FDA-regulated products. FDA performs these inspections of clinical investigators to evaluate their practices and procedures to determine compliance with applicable regulations. FDA conducts many such routine (i.e., “surveillance”) inspections each year. In addition, FDA may receive information about potential misconduct, and typically conducts an inspection of an investigator’s site to determine the investigator’s compliance.
If, as a result of the inspection, FDA notes repeated or deliberate violations or potential repeated or deliberate violations, the FDA Center having jurisdiction over the product used in the study may initiate the investigator disqualification process by issuing a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). Generally, the Center will consider issuing a NIDPOE when:
- subjects under the care of the investigator would be or have been exposed to an unreasonable and significant risk of illness or injury; or
- subjects’ rights would be or have been seriously compromised; or
- data integrity or reliability is or has been compromised.
The NIDPOE describes the alleged noncompliance and/or alleged submission of false information and offers the investigator an opportunity to explain in writing or, at the option of the investigator, at an informal conference with FDA. The NIDPOE specifies certain time frames for the investigator to respond to FDA.
If the investigator requests an informal conference, it will be held at the Center as soon as possible following the request. The investigator may bring an attorney. The informal conference may be transcribed, but the meeting is informal, and no prescribed format is required or suggested. After the meeting, the Center will review any new evidence or explanation and decide whether to proceed with the matter. In the event the Center accepts the investigator’s explanation, the Center will notify the investigator in writing of this decision.