Ask an Expert Office Hours - ICH E6(R3)

ICH E6(R3) is reshaping how sponsors and trial teams think about oversight, quality, and evidence in the Trial Master File. While the principles are clear, applying them in real TMF operations often raises practical questions.

In this Ask an Expert TMF Office Hours session, Laurel-Ann Schrader and Gill Gittens host an interactive discussion focused on what ICH E6(R3) means for TMF teams today. The session is designed as open office hours, giving attendees space to ask questions, test assumptions, and talk through real scenarios.

Discussion topics include:

How ICH E6(R3) changes expectations for TMF oversight

What risk proportionate quality looks like in practice

Evidence regulators expect to see in the TMF

Aligning processes, metrics, and documentation with R3 principles

Common areas of confusion and how teams are addressing them

This session is ideal for TMF leaders, sponsors, and functional teams looking to translate ICH E6(R3) from guidance into practical, defensible TMF practices through direct conversation with industry experts.