FDA EIR - Jeffrey S. Overcash, MD - February 03, 2017

An FDA inspection of clinical investigator Jeffrey S. Overcash, M.D., associated with eStudySite, took place from January 13, 2017, to February 3, 2017. This pre-approval, data validation inspection was conducted under Compliance Program 7348.811, which governs Clinical Investigators. The inspection focused on the conduct of a specific investigational protocol.

Key issues identified, leading to an FDA Form 483, Inspectional Observations, included significant record-keeping deficiencies. Dr. Overcash failed to maintain adequate and accurate records, evidenced by numerous transcription errors between source documents and electronic Case Report Forms (eCRFs) for adverse events, medical history, and concomitant medications. Additionally, the investigation was not conducted fully in accordance with the investigational plan; specifically, several subjects did not receive required protocol-specified assessments. These deviations represent a failure to adhere to the study's design and regulatory requirements.

In response to the observations, Dr. Overcash committed to making all necessary corrections and stated he would provide a written response within 15 business days.