2. Elements of an Organized Regulatory Binder
Training for Investigators and Research Personnel

3. What is a Regulatory Binder?
“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.”

4. https://hub.ucsf.edu/regulatory-binder-requirements
Good to Know…
“The Regulatory Binder is often the first document reviewed during audits and inspections. Not all the essential documents are available at the start of the study. Documents can be grouped into those that are generated before study initiation, those that are generated during trial conduct and those that are generated after study completion. Not all documents have to be filed in one single binder. The Regulatory Binder may sometimes consist of several binders that are stored in the same or different locations. It is important to know where all these documents are located to be able to pull them out when needed in a timely manner. The Regulatory Binder is referred to synonymously as the Study Files, Investigator Files or Investigator Binder.”

5. The Sections in a Regulatory Binder
Protocol
Original
Amendments
Informed Consent Forms (ICF)
Assent Form
Data Collection Forms used on study
Blank Case Report Forms, Data Collection Sheets, Questionnaires

6. The Sections in a Regulatory Binder
Institutional Review Board Correspondence
Initial Letter Of Approval
Letters of Continuing Review
All other outcome letters
Correspondence from Ancillary Review Committees
IBC, RSC, RDBC
Letters of Approval
Correspondence from research personnel
Meeting minutes
Principal investigator correspondence
Staff correspondence

7. The Sections in a Regulatory Binder
Staff Qualifications
Curriculum Vitaes
Medical Licenses
Human Subject Protection Training (CITI Training)
Specialized training (Ex: IATA, Site Initiation Training…)
Delegation of Authority (DOA) Log
Contact List
IRB Roster and FWA number
Lab Certifications
CAP
CLIA
Normal lab range references

8. The Sections in a Regulatory Binder
FDA Required Forms
1572
Financial Disclosure
Event Reports
Note to File
Deviations
Serious Averse Events
IND Reports
Data Safety Monitoring Board (DSMB) Reports
Monitor
Log
Queries
Reports

9. The Sections in a Regulatory Binder
Audit
Report
Subject logs
Screening log
Enrollment log
Randomization log
Specimen Tracking
Logs
Receipts
Drug or device accountability records
dispensing log
shipping and receiving records
temperature logs

10. The Sections in a Regulatory Binder
Investigator brochure
Device manual
Packet insert
Sponsor correspondence
Registration to CT.gov
Close out meeting
Final study report

11. The Sections that Should not be in a Regulatory Binder
Subject PHI
Signed Informed Consent Forms
Completed Case Report Forms
Financial Information
Contracts
Clinical Trial Agreements

12. Summary
A regulatory binder is a compilation of all necessary study documents that are maintained during the course of a study.
Regulatory binders are necessary for any clinical study that is being conducted.
Not all sections discussed are mandatory, and some of your sections may differ according to your study.
Regulatory binders should be updated frequently.

13. Resources Hand out – Regulatory Binder Checklist
Complion - A Regulatory Binder: Creating Your First Regulatory Binder ( your-first-regulatory-binder-thank-you- page?submissionGuid=6f0cc4fd-a0e8-41a5-8c55-0f2cbf2ee9a0)
Clinical Research HUB (UCSF) - binder-requirements
Harvard Catalyst - er.pdf
National Institute of Health -

14. Questions?