Regulatory Binder

Essential Documents

The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate compliance with standards of Good Clinical Practice and with all applicable regulatory requirements. Filing essential documents in a timely manner can greatly assist in the successful management of a clinical trial.

The Regulatory Binder is often the first document reviewed during audits and inspections. Not all the essential documents are available at the start of the study.  Documents can be grouped into those that are generated before study initiation, those that are generated during trial conduct and those that are generated after study completion.

Not all documents have to be filed in one single binder. The Regulatory Binder may sometimes consist of several binders that are stored in the same or different locations. It is important to know where all these documents are located to be able to pull them out when needed in a timely manner.  The Regulatory Binder is referred to synonymously as the Study Files, Investigator Files or Investigator Binder.

Organizing Your Regulatory Binder

Create tabs for each section listed below and place the appropriate documents in each corresponding section in a binder. Be sure to label the outside of the binder (cover and spine) with the protocol number, PI name, and study site. Use multiple binders or master binders to maintain documentation if needed. A sample Regulatory Binder Table of Contents is provided for your convenience.  All sections are required unless otherwise indicated.

We would like to hear from you. If you have suggestions, comments, or questions about the regulatory binder, please contact:

Marlene Berro at or at 415-476-9429

Last updated 31 Dec 2012