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Enforcement for FDA’s Requirements

To comply with the requirements, responsible parties should submit registration and summary results information for certain applicable clinical trials, as per regulations at 42 CFR 11. Until this year, the U.S. Food and Drug Administration (FDA) had not enforced this regulation.


The following is a brief timeline of FDA enforcement actions, statements, and published guidance documents. Taken together, we can start to see how the FDA is gearing up its enforcement for the requirements.

  • In August 2020, the FDA published final guidance entitled Civil Money Penalties Relating to the Data Bank. This guidance described the agency’s thinking related to how they would identify noncompliance and enforce penalties. They have not enforced civil penalties yet. According to an external compliance tracking blog’s calculations, as of 8 August 2021 the U.S. government could have imposed fines of almost $22 billion (FDAAA Trials Tracker).
  • On 27 April 2021, the FDA issued a Notice of Noncompliance. This was the first Notice ever issued that identified noncompliance with the requirements.
  • On 28 April 2021, the FDA issued a statement that they had sent over 40 Pre-Notices of Noncompliance to “encourage voluntary compliance with the requirements.” The statement did not specify which companies received the Pre-Notices.
  • On 26 July 2021, the U.S. Food and Drug Administration (FDA) issued their second Notice of Noncompliance with the requirements.


In this July Notice, the FDA identified the following:

  • Failure to update the primary completion date
  • Failure to submit results information


The FDA also referenced a previous 26 October 2020 Pre-Notice letter to the company in which they had alerted to this potential noncompliance. This previous letter requested the company to review records and submit required results promptly. The FDA further stated their intention to review again and potentially take regulatory action.

What Comes Next?

The July 2021 Notice is the second issued this year, just three months following the April 2021 Notice. This may mean that the FDA will begin more issuing Notices for noncompliance to the over 40 companies that received the Pre-Notices and did not voluntarily comply. Potentially, as they state in the July 2021 Notice, the FDA may also “initiate a civil monetary penalty.” Though as stated earlier, the FDA has never taken that action for this regulation.

Ways to Improve Compliance

There are many ways to improve compliance with 42 CFR 11 and the requirements. These include:

  • Reading FDA guidance, notices, and statements
  • Education and training about the requirements for responsible parties, organizational leadership, and research staff
  • Creating a culture of compliance

It may also be helpful to review what other organizations are doing to improve compliance. A recent report by Keyes et al. titled Creating a Program to Support Registering and Reporting Clinical Trials at Johns Hopkins University reviewed one organization’s approach to compliance through different strategies.

Further, the Clinical Trials Transformation Initiative’s (CTTI) project Challenges Meeting U.S. Reporting Requirements is conducting in-depth stakeholder interviews and surveys to develop best practices to improve compliance. The planned results of this project aim to help individuals and organizations.

CITI Program

CITI Program offers two online education opportunities to learn how to establish a reporting program to comply with regulations related to


Protocol Registration and Results Summary Disclosure in
This course guides clinical research teams through current regulations and how they impact clinical research teams. It also reviews how to enter and maintain protocol registrations and summary results information.
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Building a Compliance Program – Tips for Investigators and Institutions
This webinar covers a brief overview of the regulations, important timelines to follow, agency-specific variances, and a range of compliance mechanisms. It also covers the specific steps a major university took to build a successful compliance program to assist investigators.
View Webinar Details