Martin Throne MD – FDA EIR, Aug 5, 2016

An FDA inspection was conducted at Martin Throne MD in Atlanta, GA, from August 1 to August 5, 2016. This high-priority inspection, performed under the Bioresearch Monitoring Compliance Program 7348.811 for Clinical Investigators, focused on Dr. Throne's involvement in the Dynavax Technologies Corporation-sponsored clinical trial, "A Phase III Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age."

The inspection identified four observations concerning data recording and documentation. These included an instance where a 30-minute post-observation for a subject was not documented in the source record or reported on the deviation log. Additionally, there were three specific data discrepancies between source documents and electronic Case Report Forms (eCRFs): a subject's weight recorded as 144lbs in the source versus 114lbs in the eCRF, a negative pregnancy test in the source while the eCRF indicated it was not collected (though not required for the subject), and a subject's height recorded as 6.0 inches in the source versus 72.0 inches in the eCRF.

No formal FDA Form 483 was issued. However, these verbal observations were discussed with site management, who acknowledged the findings and affirmed the importance of accurate and complete data transcription from source documents to eCRFs. Site personnel demonstrated full cooperation throughout the inspection.