What is a regulatory binder?
A regulatory binders contains the essential documents for the conduct of a study. These documents exhibit the compliance the compliance of the institution, investigators, sponsors, and monitors with regulatory requirements. All investigators are expected to maintain regulatory binders that contain all vital study documentation.
Investigators of drug, device and biologic trials are expected to maintain “regulatory binders” that contain all vital study documentation. Even though the regulatory binder may only be required for investigators of clinical trials, its list of contents is informative for organizing records for any study. The regulatory binder includes the following items. Items of documentation that are common across most studies are bolded.
