The Site Master File (SMF) or Regulatory Binder contains essential documents. The requirement to maintain a set of essential documents within a Trial Master File (TMF) comes from International Conference on Harmonisation Good Clinical Practice (ICH GCP). GCP guidance defines essential documents as:
“…those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.”
Master Files should be established at both the Sponsor/Coordinating Center and at each local site – prior to the commencement of any research activities – and be maintained throughout the study to ensure inspection readiness. These documents can be audited by the sponsor and regulatory authorities as part of the compliance process to confirm the validity and integrity of the data and to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and all applicable regulatory requirements.
Final close-out of a trial can only be done when the monitor has reviewed the SMF and confirmed that all necessary documents are present and compliant to 1) reconstruct the conduct of the trial at the site (SMF) and 2) reconstruct the conduct of the trial as a whole (Sponsor TMF).
If need be, the contents of this binder can be expanded to other binders in any manner that maintains orderly organization and assures ready access.