Site Master File and binders

The Site Master File (SMF) is a comprehensive document that contains essential information about a clinical trial site. It includes details on the site’s personnel, facilities, equipment, standard operating procedures (SOPs), and other relevant documentation related to the conduct of clinical trials at that particular site.
Binders, on the other hand, typically refer to physical or electronic collections of documents organized and maintained by clinical trial sites or investigators. These binders contain study-specific information, such as the protocol, case report forms, informed consent forms, and other pertinent documents that are crucial for the conduct and documentation of the trial at the site level.
Both the Site Master File and binders are critical components in ensuring compliance, organization, and proper conduct of clinical trials, with the SMF providing an overarching reference for the site’s procedures and the binders housing study-specific documents at the site level.