Regulatory binder

Also referred to as the Site Master File (SMF), a physical or electronic storage medium where study-wide information, such as regulatory approvals and documents, forms, study team training records, curricula vitae (CVs), standard operating procedures (SOPs), and study-related correspondence, is housed (or if stored elsewhere, reference to where it is located is noted here).

A system of site or sponsor-created logs that allows tracking of processes (for example, IRB approval, screening, and enrollment), study supplies (for example, for study drug dispensing), and study activities (for example, screening) are also part of the regulatory binder.

The regulatory binder comprises much of what the International Council for Harmonisation (ICH) deems essential documents as they are essential to the successful execution and reproducibility of the research. CITI: Clinical Research Coordinator Foundations Course: Clinical Research Coordinator (CRC) Responsibilities