Taking A Risk-Based Approach To An Inspection-Ready Audit Trail

Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

This session covers the following topics:

• Understanding the requirements for audit trails
• How to look through all the actions and find what you are looking for
• Ways to follow your process and compare the audit trail
• How to document or show evidence of review