Webinar | February 10, 2021

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

Source: Phlexglobal

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

 

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