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

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.