Description
This Guidance document is intended to inform institutional review boards (IRBs), clinical investigators, and sponsors about the administrative action of disqualifying a clinical investigator from participating in studies involving investigational new drugs (including biologics) or devices. FDA may disqualify a clinical investigator from receiving investigational drugs (including biologics) and devices if FDA determines that the investigator has repeatedly or deliberately violated the agency’s regulations, or has repeatedly or deliberately submitted false information to the sponsor or FDA in any required report.
Scope & Applicability
Product Classes
2Drug trials conducted under an IND
Medical device being tested in a clinical trial.; Medical devices intended for participants during the trial.
Stakeholders
4Governs top dose in clinical studies
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting applications under section 524B
Decision maker in expedited withdrawal procedures; Provides opportunity for a meeting or written appeal during withdrawal procedures.; FDA Commissioner or their designee presiding over appeals
Identified Hazards
Hazards
2Basis for FDA requesting a product recall
grounds for immediate termination of IND or IDE
Related CFR Sections (8)
- 21CFR312.70§ 312.70 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50 or part 56 of this chapter , or has repeatedly or deliberately submitted to FDA or to the sponsor false informatioRead full regulation →
- 21CFR812.119§ 812.119 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50 , or part 56 of this chapter , or has repeatedly or deliberately submitted to FDA or to the sponsor false informatRead full regulation →
- 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
(a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →
- 21CFR16.22§ 16.22 Initiation of regulatory hearing.
(a) A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. The notice will—Read full regulation →
- 21CFR16.26§ 16.26 Denial of hearing and summary decision.
(a) A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom authority is delegated to make the final decision on the matter determines that no genuine and substantial issue of fact has been raised by the material submitted. If the Commissioner or hRead full regulation →
- 21CFR16.24§ 16.24 Regulatory hearing required by the act or a regulation.
(a) A regulatory hearing required by the act or a regulation under § 16.1(b) will be initiated in the same manner as other regulatory hearings subject to the additional procedures in this section.Read full regulation →
- 21CFR16.60§ 16.60 Hearing procedure.
(a) A regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a trade secret or confidential commercial or financial information that is not availaRead full regulation →
- 21CFR16.95§ 16.95 Administrative decision and record for decision.
(a) With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a) , the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory actioRead full regulation →
See Also (8)
- The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (Status: Final)
- Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry (Status: Final)
- Submitting Debarment Certification Statements (Status: Draft)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)