FDA EIR - Steven J. Glass, M.D. - March 05, 2018

An FDA inspection of clinical investigator Steven Glass, M.D., in Willingboro, NJ, was conducted from January 13 to January 26, 2009, under Compliance Program Guidance Manual (CPGM) 7348.811 for Clinical Investigators. The inspection focused on a specific drug protocol, and notably, no FDA Form 483 was issued, indicating no official objectionable conditions or significant deficiencies were identified. However, the inspection revealed several observations related to study conduct and documentation. Protocol deviations included occasional out-of-window subject visits, incomplete discontinuation visits, and the inclusion of subjects who initially met exclusion criteria (e.g., positive drug screen, alcohol/substance dependency), though these were addressed with investigator rationale or sponsor approval. Minor source document issues such as missing questionnaires, unsigned records, and slight discrepancies in adverse event reporting were also noted. Events like grogginess or drowsiness, captured in subject diaries, were not logged as adverse events, with the investigator explaining them as disease symptoms or improvements. These findings were discussed with Dr. Glass at the close-out meeting, who confirmed understanding. A previous inspection had resulted in an FDA Form 483 concerning delayed updated consent forms, for which the firm committed to voluntary corrections.