A5.3 ATR and RBQM

This presentation is part of a full breakout session. To add this presentation to your schedule you must add the full breakout session.

With the finalization of the EMA Guideline on computerized systems and electronic data in clinical trials and the inclusion of audit trial review/metadata review in draft ICH E6 R3, expectations around ATR from the regulatory perspective are clear.  But what is audit trail review really, and what do you need to know?  This presentation will provide current insights around audit trail review/metadata review from a sponsor perspective,  and touch on collaborative and regulatory perspectives as well.  Some high-level recommendations around the process will be included.