James W. Baker, MD – FDA EIR, Jun 19, 2017

The FDA conducted a 'for cause' inspection of clinical investigator James W. Baker, MD, in Portland, OR, from May 15 to June 19, 2017. This high-priority BIMO inspection, conducted under compliance program 7348.811 for Clinical Investigators and Sponsor-Investigators, was a follow-up to a previous inspection in 2016 and an OSI complaint. Dr. Baker's clinical trials involved subcutaneous and drug treatments for various conditions. The inspection revealed multiple repeat violations of Good Clinical Practice regulations. Key issues included the investigator documenting physical examinations and study activities on dates he was not present at the clinic, and failure to maintain adequate and accurate case histories regarding study visits, informed consent, concomitant medications, drug dosing, and adverse events. Repeatedly, the facility failed to follow study protocols, such as enrolling subjects who met exclusion criteria or participating in other studies during exclusionary timeframes, and conducting procedures on ineligible subjects. Additionally, study activities were performed on pediatric subjects during lapses in Institutional Review Board (IRB) approval, and one pediatric subject lacked parental permission. An informed consent form also lacked required information on compensation and medical treatments for injury. Dr. Baker acknowledged these findings, promising to prevent future deviations, retrospectively review ongoing studies for ineligible subjects, and submit a formal written response to the FDA by July 11, 2017.