Did you know that, in general, applicable clinical trials (ACTs) with a primary completion date on or after January 18, 2017, must submit results to clinicaltrials.gov within twelve months after the primary completion date?
Did you know that there are substantial civil monetary penalties in the amount of $13,237 per study, per day, that may be imposed for noncompliance with this federally mandated requirement?
eCFR :: 45 CFR 102.3 -- Penalty adjustment and table.
Did you know that the submission of these results may be delayed in some cases? Now is the time to make sure your study records on clinicaltrials.gov are current. The FDA has begun actively issuing Notice of Noncompliance to both individual principal investigators and institutions.
The Bennett Institute for Applied Data Science at the University of Oxford has created an FDAA Trials Tracker that lists ACTs in noncompliance.
https://fdaaa.trialstracker.net/
Here is a link to their study on ClinicalTrials.gov noncompliance: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33220-9/fulltext
The LLUH Research Compliance Department is available to support Principal Investigators and Study Coordinators in maintaining data integrity and compliance in all areas of research, including ClinicalTrials.gov.
Beginning in March 2023, Research Compliance will offer quarterly education on ClinicalTrials.gov registration and results submission. This education will be offered remotely and is open to anyone involved in clinical research. If you would like to be on the email list for this and other research education presentations, please feel welcome to contact:
Jerri Mendivel, Research Compliance Manager
(909) 558-9408 or Extension 49408