REMINDER: FDA Compliance with ClinicalTrials.gov

Dear UMB Researchers, 

The UMB Office of Accountability and Compliance (OAC) and the IRB are once again asking researchers who are subject to the CT.GOV regulations to log in to clinicaltrials.gov and check for problems with their records.

As noted in the emails you received earlier, the FDA is starting to impose compliance with clinicaltrials.gov requirements via fines: (https://www.fda.gov/media/148036/download?utm_medium=email&utm_source=govdelivery).  

Federal law requires responsible parties to submit registration and summary results information to the ClinicalTrials.gov data bank for certain applicable clinical trials. (NOTE: At UMB, responsible parties are the PI of the project).

FDA has the authority to issue a Notice of Noncompliance to a responsible party for failure to comply with certain requirements, including:  

  • Failing to submit required clinical trial information  
  • Submitting false or misleading clinical trial information   

The FDA has authority to assess civil money penalties for these violations. On August 31, 2021, the FDA issued a Notice of Noncompliance against an individual investigator (see Petrikovets, Andrey M.D. here: Notices of Noncompliance and Civil Money Penalty Actions | FDA).  

For reference, the FDA posted guidance on the requirements of clinicaltrials.gov compliance and civil penalties for failure to abide by these requirements:  

https://www.federalregister.gov/documents/2020/08/17/2020-17909/civil-money-penalties-relating-to-the-clinicaltrialsgov-data-bank-guidance-for-responsible-parties

Continuing reviews will not be approved if clinicaltrials.gov is not up to date. If you have any questions regarding clinicaltrials.gov, please contact hrpo@umaryland.edu. Thank you. 

 Sent on behalf of: 

 Robert Rosenthal, MD 

 IRB Chair 

University of Maryland Baltimore 

and 

Dr. Julie Doherty, DM, MSN, RN, CIP, CCEP 

Assistant Vice President, Research Compliance 

Office of Accountability & Compliance 

University of Maryland Baltimore 


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