These tabs are set up as one example of how to organize your regulatory files. There is no
requirement to have all of your regulatory information in any specific order, or all organized in a
binder, for that matter. In addition, it’s possible that not all of the supplied tabs will apply to
your study. Also, the study sponsor may have specific requirements for how this
documentation is organized and these requirements should be followed.
Your regulatory documentation can be organized as files and/or one or multiple binders in
specific locations. The requirement is that you maintain and update the appropriate
documentation for your study and that you and others on your study team are able to locate
and retrieve this information when you need to. Therefore, you should organize files in a way
that makes sense to you and your team and the type of study you are conducting. It’s a good
idea to also document the organization of files so that files may be retrieved in your absence, if
needed. A template log listing the documents is provided here for this purpose: Essential
Documents Location Log.
