Sarah Snider
May 07, 2021
Custom graphic with icons representing the various requirements for compliance

FDA Begins Issuing Notices of Non-Compliance

The FDA recently sent a Notice of non-compliance to an industry sponsor for failing to report results which could lead to large monetary penalties at the expense of the sponsor. Now, more than ever, it is important for study teams to be compliant with the federal regulations that require registration and results reporting.

The Office of Clinical Research has a robust program to facilitate compliance with registration and results reporting, however, 100% compliance can’t be achieved without the help from study teams conducting research at our site.

For those needing assistance registering, maintaining a record, or reporting results, please submit a SPARCRequest© for a Consult available through the Office of Clinical Research.

If you have any questions regarding this notice, please contact Sarah Snider, the Office of Clinical Research’s Coordinator.