February 2024 SOCRA Source Journal - Journal - Page 34
TABLE 5:
VIOLATIONS OF THE REQUIREMENTS FOR CLINICAL TRIAL REGISTRATION AND RESULTS
REPORTING
Three categories of information posted on ClinicalTrials.gov:
• Violation: Shown when the FDA issues a “Notice of Noncompliance” and posts the notice of
noncompliance on its designated webpage
• Correction: Shown when FDA confirms that the responsible party has updated the study record to
correct the violation and posts the correction notice on its designated webpage
• Penalty: Shown when the FDA imposes a penalty for the violation and posts the penalty notice on
its designated webpage
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
Pre-Notice Letter:
• Not identified in CT.gov
• 30 days to correct
Notice of Non-Compliance:
• Identified in CT.gov 30 days to correct the non-compliance
•
•
•
Corrections and penalties noted in CT.gov record
clinical trial information
Submission of false or
misleading clinical trial
information
Failure to submit primary
and secondary outcomes.
A correction is 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. Due
to the time required 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. A penalty is shown
when the FDA imposes a
34
penalty for the violation and
posts the penalty notice on its
designated webpage.
The FDA sends a Pre-Notice
Letter to the responsible party
once it has identified noncompliance. As of September
2021, the FDA had sent more
than 40 Pre-Notice Letters,
which are not considered
FDAAA 801 violations. The
responsible party has 30 days to
correct the non-compliance.
If the correction is not
made within 30 days, the
FDA will issue a Notice
of Noncompliance to the
responsible party, which will be
noted on ClinicalTrials.gov. The
responsible party is given 30
days to correct the issue. The
SOCRA SOURCE © May 2023
correction or penalty will also
be noted on ClinicalTrials.gov.
There are consequences and
penalties for non-compliance.
The NIH could withhold or
freeze grant funding. The FDA
could send a Pre-Notice Letter
or a Notice of Noncompliance.
The federal government could
also impose civil monetary
penalties or withhold other
federal grant funding. The
ICMJE can prohibit publication
of clinical trial results. The
Centers for Medicare and
Medicaid Services Billing Rule
can prohibit reimbursement for
clinical services provided during
a clinical trial.