Overview
In August 2021, the FDA issued the first Notice of Noncompliance external site (opens in a new window) to an individual investigator for a failure to submit required clinical trial results data for an Applicable Clinical Trial (ACT) external site (opens in a new window) to ClinicalTrials.gov in accordance with FDA regulations (FDAAA 801 external site (opens in a new window) ). The investigator, as the responsible party, was given 30 days from the notice to submit the required results.
On August 31, 2021, the FDA issued the first Notice of Noncompliance external site (opens in a new window) to an individual investigator (after issuing two notices to pharmaceutical companies external site (opens in a new window) ), for a failure to submit required clinical trial results data for an Applicable Clinical Trial (ACT) external site (opens in a new window) to ClinicalTrials.gov in accordance with FDA regulations (FDAAA 801 external site (opens in a new window) ). The investigator, as the responsible party, was given 30 days from the notice to submit the required results. The responsible party submitted results to ClinicalTrials.gov one day after the notice was posted.
Please note that the FDA allowed the investigator a reasonable time to respond to its notice. However, the FDA did not accept the investigator’s responses that study results could not be submitted because a manuscript was pending, or because they were short-staffed during the COVID-19 pandemic. We therefore ask researchers to consult with the UCSF ClincialTrials.gov Regulatory Support Team external site (opens in a new window) for assistance prior to responding to FDA regarding these matters.
The FDA has the authority to assess civil money penalties external site (opens in a new window) for failing to submit required clinical trial information.
More compliance actions will be forthcoming. Before receiving a Notice of Noncompliance, a responsible party will receive a Pre-Notice of Noncompliance. Both notices are delivered via UPS and email.
If you receive a Pre-Notice or Notice of Noncompliance, please contact the UCSF ClincialTrials.gov Regulatory Support Team external site (opens in a new window) . The FDA has more information here: ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions.
To check the status of your ACTs and the dates by which results are expected, please log into the ClinicalTrials.gov Protocol Registration and Results System (PRS).