SCOPE Summit for Clinical Ops Executives
Talk Quality & Monitoring track
Using Audit Trail Data to Ensure Fit-for-Purpose Data for Clinical Trials
Tue, Feb 4, 2025 · 4:25–4:45 PM EST Rosen Shingle Creek
About this session
Why is audit trail critical for ensuring quality fit-for-purpose data? How do we start with business context to define and implement a robust audit trail analytics platform? This talk will explore the need for Audit Trail Analytics (per ICH E6 R3), the cross industry working group, and discuss a hands-on way to implement this within the RBQM workflow.
