ICH E6(R3): The Birth of the (Digital) Record

In this episode, our experts will be diving into ICH E6(R3) and the shift from documents to truly digital, regulatory-compliant records. Clinical trial management is evolving, and this discussion will explore what that means for the future.Joining us for this conversation is our President & CEO, Paul Fenton-Carter, , alongside Karen Roy from Epista and Joanne Malia from Regeneron. Together, they’ll discuss what we know about ICH E6(R3) now, what's to come in the future, and how this shift will impact the industry._____________________________________________CHAPTERS: 00:00 Hot Take w/ Joanne Malia00:30 Welcome and topic intro01:03 Guest intros (Joanne Malia and Karen Roy)03:53 Important changes to the final version of ICH E6 R306:39 Areas where risk-based approach is useful08:05 ICH M11 & digital protocol10:21 Names changes, terminology & guidance documents13:26 Question from the audience (Nomenclature)15:20 ICH and the TMF Reference Model17:25 Criteria /decisionguide20:14 Timeline for TMF Ref Model V422:45 Essential records table & Records that go across studies27:05 Questions from the audience 41:33 Wrap up44:41 Outro_____________________________________________Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Joanne Malia: https://www.linkedin.com/in/jsmalia2008/Karen Roy: https://www.linkedin.com/in/karenjroy/ _____________________________________________TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-modelSubscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/Join us on Facebook: https://www.facebook.com/Montrium/