This Complion question and answer session held with Dr. Harvey Arbit, an adjunct professor at the University of Minnesota College of Pharmacy, provides insights into achieving stress-free FDA inspections.
eRegulatory Binder Checklist: What Does the FDA Require?
eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.
