Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after the study’s primary completion date.[1] In the past, some companies delayed updating a clinical trial record, including by failing to update the primary completion date to reflect delays or failing to submit results within 12 months of that date.
In August 2020, FDA announced its intention to enforce these obligations in a guidance pointedly titled, “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.”[2] The guidance emphasized the civil penalties for failure to comply with submission requirements, including financial penalties of up to $10,000 for all violations adjudicated in a single proceeding and up to $10,000 per day upon continued violation after the first 30 days following notice.
FDA announced it would identify violations through inspections conducted as part of its Bioresearch Monitoring Program and based on its evaluation of received complaints. FDA said it would send a Preliminary Notice of Noncompliance Letter (Pre-Notice Letter), identifying the noncompliance and giving the party 30 days to respond. The Pre-Notice Letter notifies the recipient that failure to comply may result in further FDA regulatory action, including the issuance of a Notice of Noncompliance (which it posts on its website) and civil penalties. FDA has issued more than 40 Pre-Notice Letters[3] and three Notices of Noncompliance, but it has not yet assessed any penalties.[4]
The new year is a good time to update your clinical trial procedures. We encourage clients to check their records for registered studies and update any primary completion dates that might have changed, consider submitting a certification in support of delayed posting of results if applicable,[5] and submit timely results. Crucially, requests for an extension to post results must be submitted before the date on which results would otherwise be due.
