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Self-Audit Workshop: Regulatory Files/Binders
March 14, 2019 @ 1:00 pm - 2:30 pm
In this interactive workshop, you’ll experience reviewing regulatory files and records. ICTR will deconstruct the audit process, share most common findings and their own tips and tricks for reviewing study records. Attendees will then apply these principles as they perform an interactive audit of provided mock regulatory files/binder. Following the mock audit, attendees will discuss and evaluate measures to address the findings, in both a reactive and proactive manner.
Tracy Ohrt, Administrative Director, FDA Regulated Research Oversight Program, ICTR
Emily Putman-Buehler, firstname.lastname@example.org