Join Gill Gittens and Laurel Ann Schrader for a practical session on risk proportionate oversight in the TMF. Learn how to move from blanket review to focused checks that protect patient safety, data integrity, and inspection readiness.
They share a simple three tier model for classifying records, show when to use automation and AI, and explain how to document rationale that meets expectations from MHRA, EMA, FDA, and ICH E6 R3. See how sponsors and CROs align accountability while keeping a human in the loop for context. Smarter TMF reviews lead to stronger compliance and future proof inspections.
You will learn:
How to classify records into high, moderate, and low risk
How to design a risk based review plan that scales
What evidence regulators expect to see during inspection
How to validate automation and maintain effective controls
How to measure results and prove oversight