COVID-19 Research Resources
A curated list of research resources around guidelines, policies, and procedures related to COVID-19, drawn from Harvard University, affiliated academic healthcare centers, and government funding agencies

A template for maintaining regulatory documentation in human subjects research. Regulatory Binder
At a glance
Key Features
  • A set of binder tabs to organize and maintain research study documentation
  • A checklist/guideline for what records to keep
  • Helps study sites achieve and maintain regulatory compliance
Useful for
  • Achieving and maintaining regulatory compliance in biomedical or social-behavioral research
  • Tracking documentation and adhering to high standards of practice in the conduct of studies involving human subjects
  • Maintaining compliance with IND/IDE regulations including sponsor obligations as an IND/IDE holder
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 Good Clinical Practice guidelines.

For Word versions of any of the tabs or logs, please email us.

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.