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.

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CHAPTERS:

00:00 Hot Take w/ Joanne Malia

00:30 Welcome and topic intro

01:03 Guest intros (Joanne Malia and Karen Roy)

03:53 Important changes to the final version of ICH E6 R3

06:39 Areas where risk-based approach is useful

08:05 ICH M11 & digital protocol

10:21 Names changes, terminology & guidance documents

13:26 Question from the audience (Nomenclature)

15:20 ICH and the TMF Reference Model

17:25 Criteria /decisionguide

20:14 Timeline for TMF Ref Model V4

22:45 Essential records table & Records that go across studies

27:05 Questions from the audience

41:33 Wrap up

44:41 Outro

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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/

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TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-model

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