Important Update:
On April 28th, the FDA issued a notice of non-compliance to an industry sponsor for failure to submit required results information to ClinicalTrials.gov. If the required information is not submitted within 30 days, the FDA may seek civil monetary penalties consisting of an initial $12,316 fine followed by daily $12,316 fines thereafter until resolved.
The acting FDA Commissioner, Janet Woodcock, MD, said:
“The FDA takes its role in enforcing the http://ClinicalTrials.gov registration and results information submission requirements extremely seriously . . . We will continue to encourage voluntary compliance with these requirements and take appropriate actions when necessary.”
Following this watershed FDA action and public statement, it is now more important than ever for study teams to be compliant with federal regulations requiring registration and results reporting.
If you have any questions regarding this notice or need assistance to register, maintain a record, or report results, please contact Monica Coudurier in the Office of Clinical Trials (m_coudurier@unc.edu).
Additional information about trial registration and results reporting can be found on the Office of Clinical Trials website under the ClinicalTrials.gov tab and the Protocol Registration and Results System (PRS) Home page (see ‘Help’ menu).