Health Providers DB includes the Food & Drug Administration (FDA) Clinical Investigators—Disqualification Proceedings, updated monthly.
Avoid potential Civil Monetary Penalties (CMP) by automating the monitoring of your employees and vendors against the HHS-OIG LEIE, GSA-SAM, and all State Medicaid Exclusion Lists, as well as the FDA Clinical Investigators—Disqualification Proceedings and FDA Debarment Lists.
The Clinical Investigators—Disqualification Proceedings is a list of clinical investigators who are or have been, subject to an administrative clinical investigator disqualification action per federal regulation 21 CFR Part §812.119.
Healthcare organizations must screen new hires and regularly monitor current employees, as well as individuals and entities they do business with, to avoid potential Civil Monetary Penalties.
About the Clinical Investigators – Disqualification Proceedings
FDA regulates scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices.
Physicians and other qualified experts (“clinical investigators”) who conduct these studies are required to comply with applicable statutes and regulations 21 CFR Part §812 Subpart E intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects to help protect the rights, safety, and welfare of those subjects.
In certain situations in which the FDA alleges a clinical investigator has violated applicable regulations, the FDA may initiate a clinical investigator disqualification proceeding.
For each clinical investigator listed, links to related FDA regulatory documents (e.g., NIDPOEs, NOOHs, Presiding Officer Reports, and Commissioner’s Decisions) are provided when available.
Below are definitions for specific terms used in clinical investigator disqualification proceedings.
NIDPOE
A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter informs the recipient clinical investigator that the FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products under the Food and Drug Administration’s regulations.
NOOH
The Notice of Opportunity for Hearing (NOOH) allows an individual to hear a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner.
Not Disqualified Clinical Investigator
The FDA may end a disqualification proceeding if an investigator provides a satisfactory response to the NIDPOE that is accepted by the relevant Center.
If an investigator’s explanation is not accepted by the relevant Center, they are entitled to an informal regulatory hearing to assess their eligibility to receive FDA-regulated test articles.
After reviewing the administrative record of a regulatory disqualification proceeding, the Commissioner of Food and Drugs may decide that the investigator remains eligible to receive FDA-regulated test articles and to conduct any clinical investigations that support an application for a research or marketing permit for FDA-regulated products.
Disqualified Clinical Investigator
The FDA has the authority to disqualify a clinical investigator if they consistently or intentionally fail to comply with relevant regulatory requirements. This action can also be taken if the investigator frequently or deliberately submits false information to the sponsor or, when necessary, to the FDA in any required reports.
A disqualified clinical investigator is not allowed to receive investigational drugs, biologics, or devices. Additionally, they are ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by the FDA. This includes drugs, biologics, devices, new animal drugs, foods (including dietary supplements that make nutrient content claims or health claims), infant formulas, food and color additives, and tobacco products.
In the past, the phrase “totally restricted” was also used to refer to clinical investigators who had been disqualified. Where an investigator has been reinstated, it is so noted.
Totally Restricted Clinical Investigator
The phrase “totally restricted” previously referred to disqualified clinical investigators.
It is essential to underscore the difference between “totally restricted” and “restricted” clinical investigators.
“Totally restricted” investigators are ineligible to receive investigational products (absent reinstatement).
Restricted Clinical Investigator
The FDA may occasionally permit a clinical investigator to enter into a restricted agreement when the agency believes that lesser sanctions than disqualification are sufficient to protect public health.
The FDA has the discretion to grant restricted agreements. A clinical investigator with such a restriction can still receive investigational products, provided they conduct regulated studies in accordance with the terms of their agreement with the FDA and adhere to all relevant regulatory requirements.
Restrictions Removed
The restrictions in the restricted agreement with the clinical investigator no longer apply and have been removed.
The investigator is again eligible to receive investigational products under all applicable regulatory requirements.
The Clinical Investigators—Disqualification Proceedings Data Collected
The Health Providers DB includes the Clinical Investigators—Disqualification Proceedings from the U.S. Food & Drug Administration in the Health Provider’s profile.
Link to the Excel download:
Health Providers DB includes links to the Disqualification Proceedings provided for reference and research.
The Clinical Investigators—Disqualification Proceedings Data Dictionary
| Field Name | Description |
|---|---|
| Name | Clinical investigator name |
| Center | FDA center |
| City | Clinical investigator city |
| State Abbreviation | Clinical investigator state |
| Status | Current clinical investigator disqualification proceedings status |
| Date of Status | Current status date |
| Date NIDPOE Issued | Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) date |
| Date NOOH Issued | Notice of Opportunity for Hearing (NOOH) date |
| Date of Presiding Officer Report | Presiding officer date |
| Date of Commissioners Decision | Commissioner’s decision date |