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U.S. Department of Health and Human Services

Science & Research

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Compliance & Enforcement

Provides links to information about clinical investigators who have and/or are participating in clinical trials of pharmaceutical products as well as regulatory correspondence and restrictions resulting from noncompliance observed during bioresearch monitoring (BIMO) inspections.

Regulatory Activities

Clinical Investigator List (PDF - 3.13 MB) 

The Clinical Investigator Inspection List, maintained by the Center for Biologics and Evaluation Research, contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER. These inspections were conducted as part of the Food and Drug Administration's Bioresearch Monitoring Program. This list contains information on inspections that were closed after 1989.

Bioresearch Monitoring Information System File (BMIS)

BMIS contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs. The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission. For example, if an investigator is named in 10 INDs, his/her name will appear 10 times in this file.

Investigational Human Drugs Clinical Investigator Inspection List

The Clinical Inspection List, maintained by the Center for Drug Evaluation and Research, contains the names, addresses and other information obtained during FDA inspections of clinical investigators who have performed studies with human investigational drugs. The list contains information on investigators inspected since July 1977 whose files have been closed with a final classification.

Warning Letters

A Warning Letter is an informal advisory to a firm communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. The Agency's policy is that a Warning Letter should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.

Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letters

These letters inform the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to FDA's regulations. Generally, FDA issues a NIDPOE letter when it believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.

Notice of Opportunity for Hearing (NOOH)

Provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner.

Adequate Assurances List for Clinical Investigators

Contains the names of all clinical investigators who have provided FDA with adequate assurances of their future compliance with requirements applicable to the use of investigational drugs and biologics.

Restrictions Removed List for Clinical Investigators

Contains the names of all clinical investigators who previously agreed to certain restrictions with respect to their conduct of clinical investigations. The decision to offer a restricted agreement is within the discretion of FDA. Under the terms of the agreements with the following clinical investigators, the restrictions in their agreements no longer apply and are removed. Clinical investigators on this list are again eligible to receive investigational products in accordance with all applicable regulatory requirements.

Restricted List for Clinical Investigators

Contains the names of all clinical investigators who have agreed to certain restrictions with respect to their conduct of clinical investigations.

Disqualified/Totally Restricted List for Clinical Investigators

Contains the names of all clinical investigators who have been disqualified or "totally restricted". FDA may disqualify a clinical investigator if he/she has repeatedly or deliberately failed to comply with all applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor.

Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings

Contains written reports and decisions concerning clinical investigator disqualifications.

Application Integrity Policy (AIP)

Describes the Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability. You can obtain information about the enforcement of this policy through this link

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