Tip of the Week Archive

FDA announced in a bulletin last week that it has issued its first Notice of Noncompliance to a responsible party of an Applicable Clinical Trial (ACT) for failing to submit required results data to ClinicalTrials.gov, and that it has issued more than 40 Pre-Notices of Noncompliance.

You may be wondering if you or your group could be at risk for similar FDA enforcement actions. We’ve put together a quick Q & A to help.

 

DOES THIS APPLY TO ME?

• If you are the PI of a CU investigator-initiated Applicable Clinical Trial, you are responsible for submitting the required registration and results data to ClinicalTrials.gov. Applicable Clinical Trials include most interventional drug or device trials that are not small Phase 1 or early device feasibility studies (i.e. < 10 participants).
• If you have registered your study, you can check whether it is an ACT by logging in and opening the record. If the “FDAAA” field at the top of the Record Summary page for the study indicates “ACT” or “pACT”, the study is an Applicable Clinical Trial.

   

  WHAT ARE THE REQUIREMENTS FOR ACTs?

• Registration must be completed within 21 days of enrollment of the first participant. (though ICMJE requires registration before beginning enrollment, so just do it before you start).
• Results data must be submitted within 12 months of the Primary Completion Date: the LAST STUDY VISIT where you collected data for your Primary Outcome Measures. These requirements and deadlines apply regardless of IRB closure, data analysis, publication, or whether the study was terminated early.

   

  WHAT IS CONSIDERED NON-COMPLIANCE?

• There are three categories of information that may be included:
  1. Failure to submit required clinical trial information
  2. Submission of false or misleading clinical trial information
  3. Failure to submit required summary results data, particularly for primary and secondary outcome measures

   

  WHAT IS A PRE-NOTICE OF NONCOMPLIANCE?

• Pre-Notices describe FDA’s identification of a potential FDAAA 801 violation that must be corrected or otherwise satisfactorily addressed (e.g. by clarification).
• If a Pre-Notice is issued, the responsible party has 30 days to correct the violation and submit the required information to ClinicalTrials.gov.
• Pre-Notices are not made public on FDA’s website or in the ClinicalTrials.gov record.

   

  WHAT IS A NOTICE OF NONCOMPLIANCE?

• If the violation is not corrected or addressed within 30 days, FDA may issue a Notice of Noncompliance. 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).
• Notices of Noncompliance are posted publicly on FDA’s website and are noted in the ClinicalTrials.gov record. These notices remain public forever, even if the problem is corrected (although the correction will be noted).  
• If the violation described in the Notice of Noncompliance is not addressed within 30 days, FDA may take additional enforcement actions, including, but not limited to, civil monetary penalties of up to $10,000 for the first violation, and $10,000 for every day after 30 days that the violation remains unresolved.

   

  HOW WOULD I KNOW IF I RECEIVED A PRE-NOTICE OR NOTICE OF NONCOMPLIANCE?

• Pre-Notices and Notices of Noncompliance are mailed to the Responsible Party, which FDA will identify using the information in ClinicalTrials.gov. For CU Investigator-Initiated studies, the notice would be sent to CU research administration leadership. We have not yet received any such notices.

 

I THINK I MAY BE AT RISK FOR CLINICALTRIALS.GOV VIOLATIONS, WHAT DO I DO?

The Clinical Research Support Center is here to help! If you are concerned about your ClinicalTrials.gov records, email clinicalresearchsupportcenter@ucdenver.edu. We can help you identify any issues and get them resolved.