FDA 483 - Shadia I. Jalal, M.D. - May 17, 2019

An FDA inspection of Indiana University Simon Cancer Center revealed significant deficiencies in clinical trial conduct and data management. The firm failed to ensure proper study monitoring, including inadequate data capture in the EDC system and non-adherence to protocol-specified accrual halts and monitoring schedules. Additionally, the investigation was not conducted in accordance with the investigational plan, and case histories contained numerous discrepancies between source documents and the electronic data capture system.