FDA 483 - Frei, Donald MD - November 01, 2018

An FDA inspection of Frei F. Donald MD, a clinical investigator in Englewood, CO, revealed a significant deficiency in informed consent practices. The firm failed to include required statements regarding confidentiality of records and the possibility of FDA inspection in informed consent documents for subjects in the ATLAS study. This indicates a failure to ensure all basic elements of informed consent were present.