Data Management – Regulatory
Binder
By: Johanna Park
Johanna.park@jefferson.edu
215-503-7572
What is a regulatory binder?
• Repository for all research study documentation
• 2 kinds of documents:
• Study-specific
• Subject-specific
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
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IRB Folder
Amendments
Annual Renewals
Approved Documents
Approval Letters
OHR-8
Regulatory Folder
FDA 1572
IRB Website
• http://www.jefferson.edu/university/human_research.html
• “Essential Study Documentation”
Questions?
Johanna.park@jefferson.edu
215-503-7572