In August 2026, the “FDA Clinical Investigators - Disqualification Proceedings” list will be added to AEB's portfolio of restricted party lists. Should this list be relevant for your company, and you wish to include it into your AEB Compliance Screening software, the “FDA Clinical Investigators - Disqualification Proceedings” list can be licensed in addition to your already existing content.
What is the meaning of this restricted party list?
The FDA, or Food and Drug Administration, is a federal agency within the U.S. Department of Health and Human Services. Its mission is to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the food supply, cosmetics, and tobacco products.
As such, FDA regulates approval studies that are 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 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 FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding. The “FDA Clinical Investigators - Disqualification Proceedings” list is a list of clinical investigators who are or have been subject to an administrative clinical investigator disqualification action. The list also indicates the current status of that action.
The original list can be found at the following URL:
https://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings
Which companies should screen against the “FDA Clinical Investigators - Disqualification Proceedings” list?
Screening against this list is relevant for companies subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Moreover, other companies may choose to conduct screening against the “FDA Clinical Investigators - Disqualification Proceedings” list if, for example, their corporate compliance policies or contractual obligations require them to do so.
Do you need to license this list if you use third-party content in Compliance Screening?
If you screen your business partners against restricted party list content from third parties - such as Reguvis or Dow Jones - in your AEB Compliance Screening application, the “FDA Clinical Investigators - Disqualification Proceedings” list may already be included in your content. In that case you do not need to license this list separately/additionally. For more information, please contact your content provider.
Efficient restricted party list screening – the “FDA Clinical Investigators - Disqualification Proceedings” list and more: How can AEB help?
The AEB Compliance Screening Module takes care of restricted party list screening against the “FDA Clinical Investigators - Disqualification Proceedings” list and performs the screening automatically in the background – upon request also integrated into SAP®, Salesforce, Microsoft Dynamics 365, and other ERP and CRM systems. Please find an overview of AEB's available restricted party lists here.
If you wish to include the "FDA Clinical Investigators - Disqualification Proceedings" List in your Compliance Screening, please request a non-binding quotation. Via the form, you can also contact a product expert.