Craig McDonald – FDA EIR, Aug 10, 2015

An FDA inspection was conducted at Craig McDonald MD, U.C. Davis Dept of Physical Med. & Rehab, from August 3 to August 10, 2015. The inspection, performed under the Bioresearch Monitoring Compliance Program (CP 7348.811), reviewed activities related to a clinical trial. While an FDA Form 483 was not issued, two discussion items concerning adherence to the investigational plan were raised. The primary issues, referenced against 21 CFR 312.60 for clinical investigator responsibilities, involved a failure to follow the study protocol for a specific subject's visit and the non-reporting of clinically significant laboratory test results as adverse events for another subject. Specifically, there was a delay in reporting a potential medical condition for a subject, which resulted in a delay in required re-testing. Additionally, a complete case history, including a testing report, was not fully maintained for this subject. Dr. McDonald disagreed with one observation regarding adverse event reporting but acknowledged the need for immediate re-testing. The management indicated that, post-study, the site implemented dedicated personnel to oversee all study-related laboratory activities, addressing the identified gaps. No samples were collected, and no refusals to provide information occurred. The inspection concluded with a general discussion with management.