FDA 483 - Kathryn Lucas, M.D. - May 22, 2015

An FDA inspection of Kathryn Lucas, M.D. in Morehead City, NC, a clinical investigator, revealed significant deficiencies in conducting an investigation according to the protocol and maintaining adequate case histories. Observations included multiple instances of protocol deviations, such as randomizing subjects with exclusionary readings and failing to follow dosing and rescue therapy procedures. Additionally, there were numerous discrepancies between source documents and eCRFs, with adverse events and concomitant medications not being accurately reported.