Contains  Nonbinding  Recommendations  
Clinical Investigator 
Administrative Actions 
 Disqualification 
 
Guidance for Institutional 
Review Boards, Clinical 
Investigators, and Sponsors 
 
 
Document issued in December 2022 
Document originally issued in May 2010 
 
 
This document supersedes the Information Sheet - Clinical Investigator Administrative 
Actions  Disqualifications issued March 2014. 
 
Additional copies are available from: 
Office of Clinical Policy  
Food and Drug Administration 
10903 New Hampshire Ave, WO32-5103 
Silver Spring, MD 20993 
Phone: 301-796-8340 
Email: gcpquestions@fda.hhs.gov    
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-
guidance-documents  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Clinical Policy  
 
 
  Contains  Nonbinding  Recommendations  
Clinical Investigator 
Administrative Actions 
 Disqualification 
 
Guidance for Institutional 
Review Boards, Clinical 
Investigators, and Sponsors 
 
 
 
NOTE: FDA made the following updates to the guidance in December 2022: 
 
   In Section D and footnote 12, updated the reference to the recently published 
FDA Staff Manual Guide on disqualification proceedings.  
   In the References Section, updated references and website links to reflect current 
versions of the referenced documents. 
 
For questions regarding this document, please contact gcpquestions@fda.hhs.gov.  
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
December 2022 
Good Clinical Practice  
 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS  
 
 
 
I.   INTRODUCTION............................................................................................................. 1  
II.   DISCUSSION ....................................................................................................................1  
A.   The Disqualification Process ......................................................................................................... 1  
1.  Notice of Initiation of Disqualification Proceedings and Opportunity to Explain .......................... 2  
2.  Consent Agreement  .......................................................................................................................... 2  
3.  Notice of an Opportunity for Hearing on Proposed Disqualification ............................................. 3  
4.  Part 16 Hearing and Final Decision on Disqualification ............................................................... 3  
5.  Actions upon Disqualification .......................................................................................................... 4  
B.   Criminal Prosecutions ................................................................................................................... 5  
C.   Disclosure of Information Regarding Disqualification Proceedings ......................................... 5  
D.   Reinstatement of a Disqualified Investigator  .............................................................................. 6  
III.   REFERENCES.................................................................................................................. 6  
  Contains Nonbinding Recommendations 
Clinical Investigator Administrative Actions  Disqualification 
Guidance for Institutional Review Boards, Clinical Investigators, 
and Sponsors1  
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic. It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the 
title page.  
I.   INTRODUCTION 
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.1 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 agencys  regulations, or has repeatedly  or deliberately submitted false 
information to the sponsor or  FDA in any required report.2  
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and  should be viewed only  
as recommendations, unless specific  regulatory or statutory requirements are cited.  The use of 
the word  should  in  Agency guidances means that something is suggested or recommended, but 
not required.  
II.  DISCUSSION 
A.  The Disqualification Process 
1  This guidance has been prepared by the Office of Clinical Policy  (OCliP), in coordination  with the Office of 
Medical Policy in the Center for Drug  Evaluation and Research (CDER), the Center for Biologics Evaluation and 
Research (CBER), the Center for Food  Safety and  Applied Nutrition (CFSAN), Center for Devices and Radiological 
Health  (CDRH), and Center for Tobacco Products  (CTP) at the Food and Drug Administration;  however, 
disqualification  actions may also be  initiated for investigators who conduct studies in support of Investigational New  
Animal Drug Applications  (INAD)  or New Animal Drug Applications  (NADA) under 21  CFR 511.1. 
2 See 21 CFR  312.70 and 812.119. Disqualification of clinical investigators conducting studies to support  INADs or 
NADAs is authorized in  21  CFR 511.1(c). 
1  Contains Nonbinding Recommendations 
 
1.  Notice of Initiation of Disqualification Proceedings and Opportunity to Explain  
 
FDAs field staff conduct on-site inspections of clinical investigators involved in the 
investigation of FDA-regulated products. FDA performs these inspections of clinical 
investigators to evaluate their practices and procedures to determine compliance with applicable 
regulations. FDA conducts many such routine (i.e., surveillance) inspections each year. In 
addition, FDA may receive information about potential misconduct, and typically conducts an 
inspection of an investigators site to determine the investigators compliance.3  
 
If, as a result of the inspection, FDA notes repeated or deliberate violations or potential repeated 
or deliberate violations, the FDA Center4 having jurisdiction over the product used in the study 
may initiate the investigator disqualification process by issuing a Notice of Initiation of  
Disqualification Proceedings and Opportunity to Explain (NIDPOE). Generally, the Center will 
consider issuing a NIDPOE when (1) subjects under the care of the investigator would be or have 
been exposed to an unreasonable and significant risk of illness or injury; or (2) subjects rights 
would be or have been seriously compromised; or (3) data integrity or reliability is or has been 
compromised. The NIDPOE describes the alleged noncompliance and/or alleged submission of 
false information and offers the investigator an opportunity to explain in writing or, at the option 
of the investigator, at an informal conference with FDA. The NIDPOE specifies certain time 
frames for the investigator to respond to FDA. 
 
If the investigator requests an informal conference, it will be held at the Center as soon as 
possible following the request. The investigator may bring an attorney. The informal conference 
may be transcribed, but the meeting is informal, and no prescribed format is required or 
suggested. After the meeting, the Center will review any new evidence or explanation and decide 
whether to proceed with the matter. In the event the Center accepts the investigators 
explanation, the Center will notify the investigator in writing of this decision. 
 
2.  Consent Agreement 
 
The Center provides a consent agreement to the investigator with the NIDPOE. Rather than 
contest the allegations set forth in the NIDPOE, the clinical investigator may opt to enter into a 
consent agreement. In general, the terms of a consent agreement provide that the investigator 
agrees that he or she will no longer conduct studies with investigational products. 
The investigator may sign the consent agreement at any time during the disqualification process 
including up to the issuance of a Commissioners decision.5  
 
Consent agreements generally take one of two forms: (1) the investigator agrees to be 
disqualified and is no longer eligible to receive investigational products. This agreement has the 
same effect as a disqualification after a Part 16 hearing and terminates the disqualification 
administrative proceeding; or, (2) the investigator, after discussions with the FDA, including an 
 
3 See Guidance For IRBs, Clinical Investigators, and Sponsors:  
FDA Inspections  of Clinical Investigators, at https://www.fda.gov/media/75185/download. 
4 Center for Drug Evaluation and Research, Center for Devices and Radiological Health, or Center for Biologics 
Evaluation and Research. 
5 The Commissioner issues his or her decision pursuant to  21 CFR 16.95, and 21 CFR  312.70 or  812.119.  
  2  Contains Nonbinding Recommendations 
 
explanation of the alleged violations in writing or at an informal conference, agrees to specific 
restrictions in the use of investigational products, such as oversight of the investigators conduct 
of an investigational study by an individual acceptable to both the investigator and FDA. If the 
investigator violates the restricted consent agreement, FDA can reinitiate the disqualification 
proceeding.  
 
3.  Notice of an Opportunity for Hearing on Proposed Disqualification 
 
If the investigators explanation (either in writing or during an informal conference) is not 
accepted by FDA or if the investigator fails to respond to the NIDPOE within the specified time 
period, FDA will offer the investigator an opportunity for an informal regulatory hearing under 
21 CFR part 16 (Part 16 hearing) to determine whether the investigator should remain eligible to 
receive certain investigational products. FDA initiates a Part 16 hearing by sending the 
investigator a Notice of Opportunity for Hearing (NOOH).  
 
The NOOH specifies the facts and other relevant information that are the subject of the Part 16 
hearing. If the investigator does not respond within the time period specified in the NOOH, FDA 
considers the offer for a hearing to have been waived, and no informal Part 16 hearing will be 
held (see 21 CFR 16.22(b)). The Commissioner will consider the information in the 
administrative record to determine whether to disqualify the investigator.  
 
4.  Part 16 Hearing and Final Decision on Disqualification 
 
If the investigator requests a Part 16 hearing and there is a genuine and substantial issue of fact 
that warrants a hearing,6 the Commissioner will designate a presiding officer to schedule and 
conduct the hearing. 
 
Once the hearing is granted, either party (i.e., the Center or the clinical investigator) may move 
for summary decision on any or all of the issues. The presiding officer reviews any motions filed, 
issues a summary decision on the issues raised, and determines whether there exists any genuine 
and substantial issue of fact to be decided at a hearing. (See 21 CFR 16.26(b)). The summary 
decision issued will be incorporated into a presiding officers report.  
 
In the alternative, if a hearing is scheduled pursuant to 21 CFR 16.24, the Center and the 
investigator will, if feasible, exchange written notices of any published articles or written 
information to be presented or relied upon at the hearing (21 CFR 16.24(g)). 
 
 
6 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. (21 CFR 16.26(a)). A hearing  will not  be  granted on  issues of  policy  
or  law; or mere  allegations  or denials of  the moving partys  evidence but must present  evidence of  its  own  that  
establishes a genuine issue of fact. If there are no genuine disputes of fact, summary decision is appropriate. 
An example of a genuine and substantial issue of fact that might warrant a  hearing is whether an investigators 
repeated changes to  data were legitimate corrections as asserted  by the investigator  or whether the changes were 
made  fraudulently to alter the outcome of the clinical trial.  In this example, the presiding officer might assess during  
the part 16 hearing the veracity  of the investigators statements about the legitimacy  of changes to the data. 
  3  Contains Nonbinding Recommendations 
 
Part 16 hearings are informal, and the rules of evidence do not apply. This means any participant 
may comment upon or rebut all data, information, and views presented (21 CFR 16.60(c)). The 
hearing begins with Center staff/counsel giving a full and complete statement of the action that is 
the subject of the hearing and describing the information and reasons supporting disqualification. 
Center staff/counsel may present any oral or written information relevant to the hearing. The 
investigator, who may be represented by legal counsel, then may present any oral or written 
information relevant to the hearing. The hearing consists primarily of the presentation of oral or 
written information, and direct and reasonable cross-examination. (See 21 CFR 16.60(b)). 
After the hearing, the presiding officer prepares a written report of the hearing (see 21 CFR 
16.60(e)). All written material presented at the hearing will be attached to the report and 
becomes part of the administrative record along with the hearing transcript (see 21 CFR 16.80). 
The presiding officers report includes a recommended decision and the reasons for the 
recommendation. When time permits, the parties are given the opportunity to review and 
comment on the presiding officers report (21 CFR 16.60(e)). 
 
The report and any comments of the parties are transmitted to the Commissioner who considers 
them as part of the administrative record to determine whether the investigator should be 
disqualified. The Commissioner then issues a written decision giving the basis for the final 
action taken. (See 21 CFR 16.95(b)). 
 
5.  Actions upon Disqualification 
 
If the Commissioner or his or her designee determines that the investigator has repeatedly or 
deliberately failed to comply with the applicable regulatory requirements, or has repeatedly or 
deliberately submitted to FDA or to the sponsor false information in any required report, the 
Commissioner will disqualify the investigator, and: 
 
(a)  Notify the investigator, the sponsor of any investigation in which the investigator has 
been named as a participant, and the reviewing IRBs that the investigator is not eligible to 
receive certain investigational products. The notification to the investigator, sponsor, and 
IRBs will provide a statement of the basis for this determination. The notification also  
will explain that an investigator determined to be ineligible to receive those 
investigational products will be ineligible to conduct any clinical investigation that 
supports an application for a research or marketing permit for products regulated by 
FDA. (21 CFR 312.70(b) and 812.119(b)). 
(b)  Notify the sponsor(s) of studies involving the investigational drug or device, and the 
sponsors of each approved or cleared application submitted under 21 CFR parts 314, 814, 
or 807, subpart E, containing data reported by the disqualified investigator, that each  
investigational new drug application (IND), investigational device exemption (IDE), and 
each approved and cleared application will need to be examined to determine whether the 
investigator has submitted unreliable data that are essential to the continuation of the 
investigation or essential to the approval or clearance of any marketing application, or 
essential to the continued marketing of an FDA-regulated product. (21 CFR 312.70(c) 
and 812.119(c)). 
  4  Contains Nonbinding Recommendations 
 
(c)  Determine whether the studies involving the investigational drug or device may 
continue.7 If the Commissioner determines, after unreliable data submitted by the 
disqualified investigator are eliminated from consideration, that the data remaining are 
inadequate to support a conclusion that it is reasonably safe to continue the investigation, 
the Commissioner will notify the sponsor who will have an opportunity for a regulatory 
hearing under 21 CFR part 16. If a danger to public health exists, however, the 
Commissioner will terminate the IND or IDE immediately and notify the sponsor and the 
reviewing IRBs of the termination.8 The sponsor will then have an opportunity for a Part 
16 regulatory hearing to determine whether the IND or IDE should be reinstated.9 (21 
CFR 312.70(d) and 21 CFR 812.119(d)). 
(d)  Determine whether the continued approval of the product is justified (e.g., any approved 
product for which the investigators data were pivotal to FDA decision-making). If 
continued approval is not justified, the Commissioner will proceed to withdraw approval 
of the product in accordance with applicable provisions of the Federal Food, Drug, and 
Cosmetic Act. (21 CFR 312.70(e) and 812.119(e)). 
 
B.  Criminal Prosecutions 
 
A disqualification does not preclude initiation of criminal proceedings against an investigator. 
Those investigators referred for criminal investigation are generally clinical investigators who 
have knowingly or willfully violated the regulations or statutes. 
 
C.  Disclosure of Information Regarding Disqualification Proceedings  
 
When FDA issues a NIDPOE to a clinical investigator, the agency provides a copy of the letter 
to the reviewing IRB and study sponsor. In addition, if the clinical investigator is disqualified, 
FDA will disclose the disqualification action to the IRB and sponsor.10 IRBs and sponsors play a 
significant role in ensuring that clinical investigators meet applicable statutory and regulatory 
requirements. This disclosure is necessary and appropriate for IRBs and sponsors to be aware of 
findings indicating violations or potential violations of the laws and regulations enforced by 
FDA.  
 
In some cases, evidence of a violation or potential violation may implicate more than one of the 
clinical investigators studies. If so, FDA may, where appropriate, share information concerning 
a violation or potential violation with the sponsors and IRBs of any of the clinical investigators 
studies. 
 
7 FDA may determine that  further use of the investigational  product should be suspended at the investigators site  
(or a more broad suspension, depending on the circumstances). However, if this  suspension could create a life-
threatening situation for a subject under the disqualified investigators care, FDA may permit that subject to 
continue to  receive or  use an investigational  product. Matters where a subject may be at risk if the study is  
suspended, among other relevant matters, may be brought to the agencys attention during the regulatory  hearing. 
8 Note: A danger to public health includes not only the subjects safety in any study in  question, but also the safety  
of subjects in other studies in  which the investigator is involved. 
9 The determination that an investigation  may not  be considered in support of a research  or marketing  application, or  
a notification or petition  submission does not, however, relieve the sponsor of any  obligation  under any  other 
applicable regulation to  submit to FDA the results of the investigation. (21  CFR 312.70(d) and  21 CFR 812.119(d)). 
10  See 63  Federal Register, October 19, 1998, at 55873. 
  5  Contains Nonbinding Recommendations 
 
 
In accordance with the above, FDA posts on FDAs Web page11 a listing of investigators who: 
 
   are ineligible to receive FDA-regulated investigational products or have agreed to some 
restricted use of FDA regulated investigational products, 
   have had restrictions removed, 
   were issued NIDPOEs,  
   were issued NOOH letters, and 
   were the subject of presiding officer reports and Commissioners decisions in clinical 
investigator disqualification proceedings. 
 
The Web page is updated regularly. FDA encourages IRBs and study sponsors to consult this 
listing for information about clinical investigators compliance with FDA regulations. 
 
D.  Reinstatement of a Disqualified Investigator 
 
An investigator who has been disqualified may be reinstated if the Commissioner determines that 
the investigator has presented adequate assurances that the investigator will employ all 
investigational products and will conduct any clinical investigation that supports an application 
for a research or marketing permit for products regulated by FDA solely in compliance with 
FDA regulations. For more information, please see the Agencys reinstatement guidelines, 
entitled FDA Consideration of Reinstatement Requests from Disqualified Clinical 
Investigators.12    
 
III.  REFERENCES  
 
1.   FDA/ORA Compliance Program Guidance; Program 7348.811, Chapter 48  Bioresearch 
Monitoring; Subject: Clinical Investigators and Sponsor-Investigators, issued July 20, 
2020; available at 
http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm1 
33773.pdf. 
 
2.   Regulatory Procedures Manual, Chapter 5  Administrative Actions, section 10  
Disqualification of Clinical Investigators; available at 
https://www.fda.gov/media/77026/download. 
 
3.   FDA Staff Manual Guides, Volume IV  Agency Program Directives, Compliance 
Activities, Disqualification of a Clinical Investigator: The Hearing Process, SMG 7711 
(effective Aug. 25, 2014, and changed on Jan. 16, 2020); available at 
https://www.fda.gov/media/80788/download. 
 
 
11 See Clinical Investigators  Disqualification Proceedings, at http://www.fda.gov/disqualificationproceedings. 
12 See FDA Staff Manual Guides, Volume IV   Agency Program Directives, Compliance Activities, FDA 
Consideration  of Reinstatement Requests from Disqualified Clinical Investigators, SMG  7715, (Sep. 2,  2021) at 
https://www.fda.gov/media/151976/download.  
  6