Amelia Spinrad, MS is currently a Regulatory Knowledge Support Administrator working at the International Center for Regulatory Science on projects with the Southern California Clinical and Translational Science Institute (SC-CTSI). She manages a regulatory research and her main project focuses on improving quality in investigator-initiated trials conducted in academia. Her prior experience as a gastroenterology research coordinator, specializing in trials related to Irritable Bowel Disease (IBD), led her to question the acceptance and degree of use of quality controls in investigator-initiated trials. In order to fill this gap, she is developing self-study tools that would be freely accessible for research professionals in academia.