data management regulatory binder by: johanna park 215-503-7572
DESCRIPTION
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 documentsTRANSCRIPT
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What is a regulatory binder?
• Repository for all research study documentation• 2 kinds of documents:• Study-specific• Subject-specific
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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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IRB Folder
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Amendments
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Annual Renewals
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Approved Documents
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Approval Letters
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OHR-8
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Regulatory Folder
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FDA 1572
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IRB Website
• http://www.jefferson.edu/university/human_research.html
• “Essential Study Documentation”