1. Data Management – Regulatory Binder By: Johanna Park Johanna.park@jefferson.edu 215-503-7572

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

3. What can you find in a regulatory binder? All versions of Protocols, Investigator’s Brochure (IB), Package Inserts 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

5. IRB Folder

6. Amendments

7. Annual Renewals

8. Approved Documents

9. Approval Letters

10. OHR-8

11. Regulatory Folder

12. FDA 1572

13. IRB Website http://www.jefferson.edu/university/human_research.html “Essential Study Documentation”

14. Questions? Johanna.park@jefferson.edu 215-503-7572