FDA EIR - William Travis Ellison MD - July 01, 2015

An FDA inspection of William Travis Ellison MD, operating as Radiant Research, Inc. in Greer, SC, was conducted from June 29 to July 1, 2015. This was a high-priority, directed inspection under FDA's Clinical Investigator program (CP7348.811), focusing on the conduct of a clinical trial for a viscoelastic hydrogel in treating knee osteoarthritis. The inspection identified several minor deviations. Key observations included five instances where unblinded study personnel performed Clinical Observer Global Assessments (COGA), a task designated for the blinded evaluator. Documentation issues were also noted, specifically uninitialed and undated cross-outs and write-overs in investigational product accountability logs, and unclear identification of individuals performing COGAs. Furthermore, one subject signed the core consent form at the baseline visit instead of screening, and the site utilized an earlier approved version of the screening consent when a more recently approved version, though with incorrect address information, was available. Despite these findings, no FDA-483 (Inspectional Observations) was issued. During the final discussion, management acknowledged the observations and committed to addressing them by reminding staff about proper document correction procedures, ensuring clear task documentation, and emphasizing stricter adherence to blinding protocols for future studies. The site indicated an increased focus on blinding procedures for future blinded clinical trials.