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Creation of a quality assurance and Regulatory Specialist role: A pilot study

Elizabeth E Robison¹, Devon M Estes¹, Jaskaran S Halait¹

¹University of California, Davis, Medical Center, Infectious Diseases Research Unit, United States.

Contemporary Clinical Trials Communications

|October 3, 2026

Abstract:

Quality assurance activities and research compliance activities are paramount to a healthy and successful research program to ensure participant safety and data integrity are upheld. The UC Davis Infectious Diseases Research Unit (IDRU) supports both interventional and observational research, and about half our portfolio consist of studies that are observational. This article will discuss our experience in creating a unique Quality Assurance and Regulatory Specialist role and how it impacted the quality of research in our unit.

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...

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