David E. Dong – FDA EIR, Nov 20, 2012

An FDA inspection of David E. Dong, M.D., Principal Investigator at Puget Sound Cancer Center in Seattle, WA, was conducted from October 18 to November 20, 2012. This for-cause inspection, initiated under Compliance Program 7348.811 for Bioresearch Monitoring of Clinical Investigators and Sponsor-Investigators, reviewed the conduct of a clinical study involving an investigational drug. The inspection identified several significant issues, which were documented on a Form FDA 483, Inspectional Observations. These included failures to conduct the investigation in accordance with the study protocol, inadequate records for investigational drug disposition regarding dates, quantity, and subject use, and a failure to promptly report a Serious Adverse Event (SAE) to the study Sponsor. Additionally, Dr. Dong's site failed to maintain accurate case histories and to retain complete study records, specifically noting incomplete ambient temperature logs for the clinical pharmacy. Further concerns discussed during the closing meeting, though not listed on the 483, involved delayed reconsent for one subject, allegations of an unprompted informed consent by a sub-investigator, incomplete end-of-treatment evaluations, inconsistent performance documentation, limited training records, and an uncalibrated chart recorder for investigational drug storage conditions. It was also noted that a sub-investigator performed study-related procedures prior to being included on the Form FDA 1572 and before completing financial disclosure, alongside incomplete investigator assessment of adverse events. Dr. Dong pledged to provide a written response to the Form FDA 483 within 15 business days.