Tip of the Week Archive

Users of the public-facing ClinicalTrials.Gov site can now use the Advance Search function to search for study records with Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) Violations.

 

The following definition for 'FDAAA 801 Violations' has been added to the Glossary:

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FDAAA 801 Violations

A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug Administration (FDA) has issued a Notice of Noncompliance to the responsible party of an applicable clinical trial. A Notice of Noncompliance indicates that the FDA has determined the responsible party was not in compliance with the registration or results reporting requirements for the clinical trial under the Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801).

The National Library of Medicine (NLM) is required by FDAAA 801 to add information to a study record about any FDAAA 801 Violation. This information is provided by the FDA. There are three categories of information that may be included:

• Violation: Shown when the FDA issues a Notice of Noncompliance and posts the Notice of Noncompliance on its designated webpage. There are three types of violations:
• Failure to submit required clinical trial information
• Submission of false or misleading clinical trial information
• Failure to submit primary and secondary outcomes
• Correction: Shown when the FDA confirms that the responsible party has updated the study record to correct the violation and posts the correction notice on its designated webpage. Because of the time for FDA review and processing, there may be a delay between the date when the study record was updated and the addition of correction information to the FDAAA 801 Violation information.
• Penalty: Shown when the FDA imposes a penalty for the violation and posts the penalty notice on its designated webpage.

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NLM will add FDAAA 801 Violations to study records based on information provided to them by the FDA. According to FDA’s guidance.

 

• FDA generally intend(s) to identify violations relating to the ClinicalTrials.Gov data bank through evidence collected during inspections, or based on the evaluation of complaints received by the Agency.

   

• If FDA suspects a violation, they intend to send a Preliminary Notice of Noncompliance (Pre-Notice) Letter to the responsible party, identifying the potential violation and requesting that the responsible party address it within 30 calendar days.

   

• If the matter is not resolved within 30 days, FDA may take further regulatory action, including (but not limited to) issuing a Notice of Noncompliance.

 

Only violation that resulted in a Notice of Noncompliance (not a Pre-Notice) being issued will be added to the ClinicalTrials.Gov records. Corrections to violations resulting in a Notice of Noncompliance that are confirmed by FDA and posted to their webpage will be added to the record, but will not “clear” the FDAAA 801 Violations indication from the record.

 

For help with your ClinicalTrials.Gov record, contact clinicalresearchsupportcenter@ucdenver.edu.