Data Management – Regulatory Binder

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Presentation transcript:

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

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

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 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

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 “Investigator & Coordinator Resources” “Essential Study Documentation”

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