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.

General Guidance for Using the Regulatory Binder

Tailor the binder to meet the needs of your specific protocol:
  • The Regulatory Binder is a template. Include only sections pertinent to your protocol.
  • Omit unused sections and add sections as needed.
  • Organize and order the sections to facilitate easy use and reference, e.g., file most used and referenced sections in the front of the binder.
  • Add additional tabs and/or documents to each section as needed.
  • Keep the Regulatory Binder current and up-to-date.
  • Identify an individual(s) responsible for maintaining the binder. Ensure that this person is on file with the IRB as an Additional Person to Contact to ensure that all IRB correspondence and documents are received/filed in a timely manner.
  • Store binder in a safe and secure location, but accessible to study staff at all times.
  • Participant-specific documentation and information, e.g., signed consent forms, test results, and completed case report forms, should be maintained separately in participant-specific binder/file.

Each Harvard Catalyst-affiliated institution may have additional regulatory requirements or guidance not covered by the materials in the binder. Investigators are encouraged to contact their institutional Quality Assurance/Quality Improvement (QA/QI) office for details.