1. Data Management – Regulatory Binder
By: Johanna Park

2. Learning Objectives: Attendees will be able to:
Identify what documents are found in a regulatory binder
Organize and save all IRB and regulatory documents electronically on department shared drives

3. What is a regulatory binder?
Repository for all research study documentation
2 kinds of documents:
Study-specific
Subject-specific

4. What can you find in a regulatory binder?
All versions of Protocol, Investigator’s Brochure (IB), Package Insert
Signature Pages
Institutional Review Board (IRB) documents
Sponsor and Clinical Research Organization (CRO) correspondence
Delegation and Training Logs
Conflict of Interest (COI)/Financial Disclosure Forms (FDF)
Curriculum vitae (CV), Licenses, Collaborative Institutional Training Initiative (CITI)/Good Clinical Practice (GCP) Trainings
Lab certifications
Lab normals
Subject-specific documents

6. IRB Folder

7. Amendments

8. Annual Renewals

9. Approved Documents

10. Approval Letters

11. OHR-8

12. Regulatory Folder

13. FDA 1572

14. IRB Website http://www.jefferson.edu/university/human_research.html
“Investigator & Coordinator Resources”
“Essential Study Documentation”

15. Questions?