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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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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
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”
