Federal law requires responsible parties to submit registration and summary results information to the ClinicalTrials.gov data bank for certain applicable clinical trials. The law also requires a submitter of certain applications/submissions to FDA certify that all the above-referenced requirements have been met for applicable clinical trials referenced in such applications/submissions. 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  

FDA also has the authority to issue a Notice of Noncompliance to a submitter who has failed to submit or knowingly submitted a false certification to FDA.

FDA has authority to assess civil money penalties for these violations. If a responsible party does not take adequate corrective action within 30 days after receiving a Notice of Noncompliance regarding failure to submit required information, that responsible party may be subject to additional civil money penalties. 

FDA will take into consideration any corrective action that is taken by a responsible party after receiving a Notice of Noncompliance when considering civil money penalties. See Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank and 21 CFR part 17 for more information.

Notices of Noncompliance

The table below lists the Notices of Noncompliance sent by FDA and the amount of civil money penalties assessed, if any, for each responsible party or submitter listed.

Resources

• FDA's role: ClinicalTrials.gov information
• Federal register notice: Delegation of authority
• Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
• 21 U.S.C. 333(f)(3) 
• 42 U.S.C. 282(j) 
• 21 U.S.C. 331(jj)
• 21 CFR part 17
• 42 CFR part 11