Monitoring & Managing a Research Team

Ensure your team is inspection-ready with monitoring best-practices, corrective action plans, and study personnel transitions.

Quick Reference Guides

• Standard Operating Procedure (SOP) Overview
• Writing SOPs Tips & Templates
• Guide to Hiring Clinical Research Coordinators, Nurses & Assistants
• Overview: Corrective And Preventive Action (CAPA) Plans
• Corrective and Preventive Action (CAPA) Plans [IRB]
• How do I fulfill ClinicalTrials.gov requirements?
• Preparing for an IRB Post-Approval Monitoring Visit [IRB]
• Preparing for a FDA Inspection [IRB]

Document Templates & Checklists

• Consult the “NU Documentation” section of our templates page for items frequently requested by industry study monitors (CRA’s)
• Corrective & Preventive Action Plan Examples [IRB]
• View the full library of Regulatory Document Templates

Video Resources

• Presentation: Quality Management in Clinical Research [NIH]
• Presentation: Developing a Manual of Operating Procedures (MOPS) [NIH]
• LinkedIn eCourse: Foundational Skills for New Managers [~1hr, NU Login Required]
• Webinar: Maintaining Effective Communication with Mentees/Direct Reports
• Webinar: Creating SMART Goals