Study Approval & Compliance

Initial study approvals, continuing reviews, and best practices on maintaining regulatory binders. 

Quick Reference Guides

• Regulatory Binder Basics
• Delegation Log Considerations
• Standard Operating Procedure (SOP) Overview
• Writing SOPs Tips & Templates
• Corrective And Preventive Action (CAPA) Plans
• NU IRB Submission & Initial Approval
• NU IRB Continuing Reviews & Closure
• How do I submit initial and continuing reviews in eIRB?
• Conflict of Interest Reporting Requirements [COI Office]
• Checklist for translational studies involving animals [IACUC]
• External IRB’s/Reliance Agreements and NU serving as an IRB of Record [NU IRB]
• View content from past IRB Information Sessions
• View additional Study Initiation resources

Document Templates & Checklists

• Pre-IRB Submission Checklist [IRB]
• Initial Review Worksheets [IRB]
• Regulatory Binder & Research Record Components [IRB]
• Delegation of Authority (DOA) Log Template [IRB]
• Visit our full library of Regulatory Document Templates 

Video Resources

• Webinar: Compliance Keys for Clinical Trials
• Presentation: Common Compliance Pitfalls & Case Studies [NIH]
• Presentation: Legal Issues in Clinical Research [NIH]