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What actions can FDA take to address clinical investigator misconduct?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

If an inspection conducted by FDA reveals that a clinical investigator has committed violations of FDA's regulations, FDA generally will notify the investigator of the violations and take appropriate follow-up action. This notification may consist of the Form FDA 483 (Inspectional Observations) issued at the close of this inspection, or it may be in the form of a Warning Letter. In some cases, an investigator's agreement to correct the violations may be sufficient to resolve the matter. Where FDA finds that there have been serious violations of the investigator's obligations, and corrective action by the investigator cannot resolve the matter, FDA may conclude that it is appropriate to initiate an enforcement action against the investigator. First, if the inspectional findings indicate that the investigator has repeatedly or deliberately violated FDA regulations or repeatedly or deliberately submitted false information, FDA may move to disqualify the investigator from conducting future studies regulated by FDA. Second, FDA may initiate a civil or criminal enforcement action in federal court. Such actions can take several months and frequently years to complete.

To disqualify a clinical investigator, FDA must go through an administrative process involving an opportunity for hearing. When a Center (i.e. CBER or CDER) has reviewed the inspectional findings and determined that there is evidence of repeated or deliberate violations or repeated or deliberate submission of false information, and that the pattern or severity of the misconduct warrants agency action, the Center issues a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter, which furnishes the investigator with written notice of the matter and offers the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an informal conference is held, the investigator may bring an attorney. If, after hearing the investigator's explanation, the Center still believes that the investigator's actions meet the threshold for disqualification, the Center must offer the investigator an opportunity for a regulatory hearing, whose procedures are governed by 21 CFR Part 16. The investigator may enter into a consent agreement or may request a hearing. At a regulatory hearing, the investigator may offer the testimony of witnesses, documentary evidence, and supporting briefs. After the hearing, the presiding officer issues a report or decision on whether the investigator has repeatedly or deliberately violated the regulations and should be disqualified. The report is forwarded to the Commissioner, who then issues a Commissioner's decision on disqualification (21 CFR Part 16). The investigator may appeal the Commissioner's decision in federal court. A disqualification proceeding generally takes many months or years to complete.

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