Avoid potential Civil Monetary Penalties (CMP) by automated monitoring of HHS-OIG LEIE, GSA-SAM, and all State Exclusion Lists, as well as the FDA Clinical Investigators—Disqualification Proceedings and Debarment Lists.
Our Healthcare Provider Profiles include the Food & Drug Administration (FDA) Clinical Investigators—Disqualification Proceedings.
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.
It is essential for healthcare organizations that test, manufacture, administer, market or distribute pharmaceuticals or other clinically tested products to screen individuals and entities to avoid Civil Monetary Penalties (CMP).
Health Providers DB updates the Healthcare Provider Profiles with the Clinical Investigators—Disqualification Proceedings database monthly.
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 discontinue a disqualification proceeding when an investigator explains a response to the NIDPOE accepted by the applicable Center.
Suppose an investigator offers an explanation but is not accepted by the applicable Center. In that case, the investigator is allowed for an informal regulatory hearing to determine whether the investigator should remain eligible to receive FDA-regulated test articles.
After reviewing the administrative record of a regulatory disqualification proceeding, the Commissioner of Food and Drugs may determine that the investigator should continue to be eligible to receive FDA-regulated test articles and to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.
Disqualified Clinical Investigator
The FDA may disqualify a clinical investigator if the investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or has repeatedly or intentionally submitted false information to the sponsor or, if appropriate, to the FDA in any required report.
A disqualified clinical investigator is not eligible to receive investigational drugs, biologics, or devices and is not eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by the FDA (including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, 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, in some instances, allow a clinical investigator to enter into a restricted agreement when the agency believes that lesser sanctions than disqualification would be adequate to protect public health.
The decision to offer a restricted agreement is at the discretion of the FDA. A restricted clinical investigator is still eligible to receive investigational products, provided the investigator conducts regulated studies by the restrictions specified in their agreement with the FDA and all applicable 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.
| 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 |