Regulatory Binder

The Code of Federal Regulations (CFR) requires a number of specific documents to be completed and maintained for all research studies. The Regulatory Binder is designed to provide an organizational template for achieving and maintaining regulatory compliance in the conduct of human research. It creates a framework for storing all essential study-specific information and regulatory documentation in one place for audits and inspections.

Required regulatory documents include, but are not limited to, the following:

• Protocol
• Investigator Brochure
• Delegation of Authority Log
• FDA Form 1572: Statement of Investigator
• Curriculum Vitae (CV)
• License(s)
• Laboratory CAP and CLIA
• Financial Disclosure forms
• Enrollment Log
• IRB Documents and Approvals
• Informed Consent Form
• Subject Enrollment and Screening Logs
• Drug/Device Information

For further assistance from a member of the Research and Innovation staff, please submit a consultation request.

Helpful Links

ICH GCP Guidelines

• 2.11 – The Principles of ICH GCP
• 4.9.4 – Investigators: Records and Reports
• 4.9.5 – Investigators: Records and Reports
• 5.5.12 – Sponsor: Trial Management, Data Handling, and Record Keeping

FDA Code of Federal Regulations

• 21 CFR 312.62 – Investigator recordkeeping and record retention
• 21 CFR 312.68 – Inspection of investigator's records and reports

Research & Innovation SOPs

• RA 201 – Regulatory Affairs – Essential Documents (PDF, 176KB)
• RA 201A – Regulatory File Content Checklist (PDF, 152KB)
• RA 201B – Study File Content Checklist (PDF, 78KB)
• RA 201C – Table of ICH Essential Documents (PDF, 180KB)