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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 26

Electronic trial master file: an important step in documenting clinical trial data used to support a premarket tobacco product application

RAI Services Company, Winston-Salem, NC, USA

Before introducing a new tobacco product to the US market, companies are required to submit a Premarket Tobacco Product (PMTA) application to the FDA and receive authorization. This application comprises data generated across multiple scientific disciplines to collectively demonstrate that the product is appropriate for the protection of public health. Clinical trial data is key to this scientific evidence as it directly represents potential risks and benefits of new tobacco product use in humans. Clinical studies are often lengthy endeavors with potentially large numbers of subjects and study conditions conducted across multiple study sites. These studies produce vast quantities of documentation including every record associated with each subject’s participation in the trial. All this information must be tracked, verified, and stored in a way that is easily accessible upon request, as per regulatory requirements. For clinical trials, regulatory compliance may be maintained through implementation of an electronic trial master file (eTMF) process. Our company has used eTMF for the past ten years to simplify clinical trial documentation management, including tracking, maintaining, and storing data and documents related to clinical study conduct. This secure database ensures all records associated with the clinical trial are managed in compliance with FDA regulations promulgated under good clinical practice (GCP), HIPPA and FDA 21CFR Part 11. Moreover, the archived eTMF documents are retrieval-ready in human-readable electronic formats for regulatory applications, inspections, or review.

Over the past few years, use of eTMF has helped facilitate rigorous quality standards for clinical research studies within the tobacco industry and provided substantiation of clinical evidence supporting applications that have resulted in receipt of FDA Marketing Granted Orders for a selection of new tobacco products.