The Food and Drug Administration (FDA) is taking action to ensure certain information in ClinicalTrials.gov is available to the public. On April 28, 2021, the FDA issued its first notice of non-compliance for failing to submit required results information.
A Notice of Noncompliance indicates that the FDA has determined the Responsible Party (Principal Investigator) 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). Categories of information include failure to submit required clinical trial information, submission of false or misleading clinical trial information, and failure to submit results reporting for primary and/or secondary outcomes.
The FDA warning letters are sent to Principal Investigators (PIs). A Pre-Notice letter notifies the PI of the delinquency, allows thirty days to update required information, and no record of non-compliance is noted. If the information is not updated within the allotted time, a second Notice of Noncompliance letter is disseminated. The second notice grants 30 days to update required information, but the non-compliance is noted in clinicaltrials.gov, and correction or penalty is noted in the record. Penalties per the FDA, can include civil monetary penalties and criminal prosecution.
If you receive a pre-notice or notice from the FDA regarding ClinicalTrials.gov, contact the Office for Clinical Research (OCR) immediately for assistance. For more information about ClinicalTrials.gov, visit the Emory OCR ClinicalTrials.gov website at http://www.ocr.emory.edu/ct.gov/index.html.