Data Management – Regulatory Binder

By: Johanna Park

Johanna.park@jefferson.edu215-503-7572

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

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.edu215-503-7572