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  5. Clinical Investigations Compliance & Enforcement
  1. Clinical Trials and Human Subject Protection

Clinical Investigations 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

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 on clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of clinical studies conducted under an Investigational New Drug (IND) application with human investigational drugs and therapeutic biologics who are listed on a Form FDA 1572 submitted to CDER.  BMIS is therefore not intended to provide a comprehensive list of all CIs, CROs or IRBs involved in clinical research.

Investigational Human Drugs Clinical Investigator Inspection List

The Clinical Investigator Inspection List (CLIIL) is maintained by the Center for Drug Evaluation and Research and 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 clinical investigator inspections conducted since October 1, 2008, and that have a final classification.

Institutional Review Boards – Restrictions Imposed Letters and Disqualification Proceedings

An Institutional Review Board – Restrictions Imposed Letter (Restrictions Letter) is a noncompliance letter issued under 21 CFR 56.120(a) that imposes restrictions on the IRB in accordance with 21 CFR 56.103 and 56.120(b).  IRBs that refuse or repeatedly fail to comply with any of the applicable regulations and whose noncompliance adversely affects the rights or welfare of the human subjects in a clinical investigation may be subject to an administrative IRB disqualification action.  This page indicates the current status of IRBs that have received Restrictions Letters or are the subject of disqualification actions.  For each IRB listed, links to related FDA regulatory documents (e.g., IRB Restrictions Letters, NOOHs, Presiding Officer Reports, Commissioner's Decisions) are provided, when available.

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.

Clinical Investigator-Disqualification Proceedings

FDA's new Clinical Investigator - Disqualification Proceedings database provides a list of clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action.  For each clinical investigator who is listed, links to related FDA regulatory documents (e.g., NIDPOEs, NOOHs, Presiding Officer Reports, Commissioner's Decisions) are provided, when available.

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

Notice of Opportunity for Hearing (NOOH) - Proposal to Debar

The Notice of Opportunity for Hearing provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as debarment), before a presiding officer designated by the Commissioner.

FDA Debarment List

Firms or individuals convicted of a felony under Federal law for conduct (by a firm) relating to the development or approval, including the process for development or approval, of any abbreviated drug application; or (an individual convicted) for conduct relating to development or approval of any drug product, or otherwise relating to any drug product under the Federal Food, Drug, and Cosmetic Act.

 



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