Regulatory Binder

Key Features

  • Template set of binder tabs to organize and maintain study documentation
  • Helps study sites ensure compliance with IND/IDE and other federal regulations
  • Useful for biomedical or social-behavioral research
  • Available to all members of the Harvard Catalyst community

The Regulatory Binder is a template and guidance document for tracking documentation associated with studies involving human subjects. It is designed to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects.

The binder is divided into several sections, each of which outlines regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and guidelines for good clinical practice.

For Word versions of any of the tabs or logs, please email regulatory@catalyst.harvard.edu.


General Guidance for Using the Regulatory Binder

  • These Regulatory Binder tabs should serve as a template. It is important to note that one size does not fit all when it comes to regulatory documentation. You must tailor the binder to meet the needs of your specific protocol. Your institution may have additional documentation requirements not outlined in this template.
  • Organize and order the sections to facilitate easy use, reference, and retrieval.
  • Keep the Regulatory Binder current and up to date.
  • Store binder in a safe and secure location, but accessible to study staff at all times.

Electronic Regulatory Binder Project

The eReg Binder is a REDCap project developed by the Mass General Brigham Human Research Quality Improvement (QI) Program and Enterprise Research Infrastructure & Services (ERIS). The eReg Binder assists sites with the electronic storage and maintenance of regulatory documents for IRB-approved protocols. The eReg Binder is available through the REDCap consortium.