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What will occur when an investigator is disqualified?

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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 the Commissioner or his or her designee determines that the investigator has repeatedly or deliberately failed to comply with the applicable regulatory requirements, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Commissioner will disqualify the investigator, and:

  • Notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing IRBs that the investigator is not eligible to receive certain investigational products. The notification to the investigator, sponsor, and IRBs will provide a statement of the basis for this determination. The notification also will explain that an investigator determined to be ineligible to receive those investigational products will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.
  • Notify the sponsor(s) of studies involving the investigational drug or device, and the sponsors of each approved or cleared application submitted under 21 CFR parts 314, 814, or 807, subpart E, containing data reported by the disqualified investigator, that each investigational new drug application (IND), investigational device exemption (IDE), and each approved and cleared application will need to be examined to determine whether the investigator has submitted unreliable data that are essential to the continuation of the investigation or essential to the approval or clearance of any marketing application, or essential to the continued marketing of an FDA-regulated product.
  • Determine whether the studies involving the investigational drug or device may continue. If the Commissioner determines, after unreliable data submitted by the disqualified investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Commissioner will notify the sponsor who will have an opportunity for a regulatory hearing under 21 CFR part 16. If a danger to public health exists, however, the Commissioner will terminate the IND or IDE immediately and notify the sponsor and the reviewing IRBs of the termination. The sponsor will then have an opportunity for a Part 16 regulatory hearing to determine whether the IND or IDE should be reinstated.
  • Determine whether the continued approval of the product is justified (e.g., any approved product for which the investigator’s data were pivotal to FDA decision-making). If continued approval is not justified, the Commissioner will proceed to withdraw approval of the product in accordance with applicable provisions of the Federal Food, Drug, and Cosmetic Act.

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