Are there penalties if I fail to register or submit results on ClinicalTrials.gov?

FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.                                                         

Any person who violates the provisions of the FDAAA 801 may be subjected to penalties up to $10,000.  After 30 days of notification, uncorrected violations could incur additional $10,000 daily penalties until the violation is corrected. 

Please be aware that all correspondence from the University of Utah FDA Clinical Research Compliance Officer should be taken seriously and any issues need to be addressed in a timely manner, to ensure compliance of the ClinicalTrials.gov registry requirements.

Further Information:

Civil Money Penalties

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=98

Clinical Trials Supported by Grants from Federal Agencies

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=95

 

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