Regulatory Binder Table of Content Page

The Regulatory Documentation maintained during a clinical trial allows the Investigator and study team to demonstrate their compliance with regulations designed to protect Human Subjects who volunteer to participate in a Clinical Trial. When conducting an Industry Funded Clinical Trial or an Investigator Initiated Clinical trial the minimal amount of documentation should be maintained in a "Central File". The regulatory information is not patient specific information, but is just as critical to the practive of conducting Clinical Trials consistent with Good Clinical (Research) Practices. This file can be audited for completeness and accuracy by Federal and Institutional Officials responsible for the oversight of Clinical Trials.

This is a Table of Content Outline for establishing a Regulatory File and may or may not include all of the information depending on the scope of your trial. If you have questions or need assistance with creating a Regulatory File please contact the Clinical Trials Office.

Study Related Documents

Research Protocol including Protocol Amendments

IRB Certificate of Approval Issued by the IRB

IRB Approved Informed Consent Documents

HIPAA Authorization Form

Investigator Drug Brochure/Investigational Device Brochure

FDA Form 1572 – (Investigative New Drug Studies)

Laboratory Documents (CLIA, CAP, Normal Value Ranges)

Research Personnel Information

Curriculum Vitae

Medical License

Financial Disclosure Documentation

Human Research Protections Certification

Study Tracking Logs

Subject Screening Logs

Subject Enrollment Logs

Monitoring Visit Logs

Investigational Product Accountability Logs

Correspondence

Sponsor Correspondence

Institutional Review Board Correspondence Including Interim Reports and Approvals

Other Institutional Review Committee's Correspondence which are responsible for the Oversight of the Clinical Trial as applicable