FDA EIR - Jonathan E. Rosenberg, MD - March 15, 2016

An FDA clinical investigator inspection of Jonathan E. Rosenberg, MD, at Memorial Sloan-Kettering Cancer Center in New York, NY, was conducted from March 10-15, 2016. The inspection, performed under the Food, Drug and Cosmetic Act for a drug product study (protocol GO29293), aimed to assess compliance with regulatory requirements. Although no formal FDA Form 483 (Inspectional Observations) was issued, several significant discrepancies were verbally discussed with management during the close-out meeting. Key issues identified included the untimely reporting of three Serious Adverse Events (SAEs), which were reported outside the stipulated timeframe. For these, the site had subsequently reported them as protocol violations, re-trained staff, and ensured awareness from both the sponsor and the Institutional Review Board. Additionally, the inspection revealed discrepancies where data entered by the site into the Electronic Data Capture (EDC) system for eleven subjects' Adverse Events and three subjects' Concomitant Medications were not reflected in the sponsor's corresponding line listings. A further data inconsistency was noted for one subject regarding efficacy endpoint information between the site's records and the sponsor's listing. While no formal regulatory actions were imposed, these discussions highlighted areas requiring enhanced data management and reporting accuracy.