Regulatory Binder

The Harvard Longwood Campus (HLC) Quality Improvement Program has developed a template “Regulatory Binder” for organizing and maintaining physical as well as electronic regulatory documentation. Our template offers input regarding both requirements as well as best practices for which documents to maintain during and after conducting a study.

How to Use our Template

In order to create your own Regulatory Binder, print the Regulatory Binder Tabs . You can use these tabs to help keep your regulatory documentation for each study organized and easily accessible. Follow the instructions on each tab regarding which documents to keep behind it as well as our “QIP Tips” for additional advice from our staff. In your binder only include the tabs that are appropriate for your specific study and remove the others.

In this day and age, most documentation is kept electronically. If this is the case for your study, simply organize your files according to the regulatory binder tabs in electronic format using file folders on your computer, shared drive, or cloud based database (see image below).