FDA EIR - William J. Muller, M.D. - April 08, 2025

An FDA inspection of William J. Muller, M.D., a clinical investigator affiliated with Ann and Robert H. Lurie Children’s Hospital of Chicago, took place from March 31 to April 8, 2025. This high-priority inspection, conducted under the PDUFA BIMO review program and Compliance Program 7348.811 for Clinical Investigators and Sponsor-Investigators, evaluated the conduct of clinical trials. Although no formal Form FDA 483 was issued, several significant issues were discussed with Dr. Muller at the inspection's conclusion. Main issues included deficiencies in source documentation, such as the use of informal notes (e.g., sticky notes, paper napkins) for critical data, instances of unsigned or undated informed consent forms, and direct entry of adverse event details into the Electronic Data Capture (EDC) system without corresponding source records. Discrepancies were also identified between source documents, the EDC, and provided data listings across various data points. The documentation of Adverse Events and Serious Adverse Events, including awareness dates, severity, and sponsor notification, required improvement. Dr. Muller acknowledged these findings, committing to implement corrective actions. These actions involve enhancing internal quality assurance processes, ensuring comprehensive and accurate source documentation prior to EDC entry, adhering to Good Clinical Practice standards for record-keeping, improving AE/SAE documentation, and resolving data discrepancies for future studies. He was advised that the observed conditions may be considered violations of the FD&C Act.