The Trial Master File (TMF) is the repository for all essential documents supporting a clinical trial. But its role is going beyond a simple storage container for files, as CROs and Sponsors work together to manage not only the collection of TMF documents but also the review and inspection processes, both internally and externally.

In this episode, Agatha’s Head of North American Operations, Ken Lownie, and Kari Brown, Director of Clinical Operations, DZS Clinical Services, discuss:

• The role of the TMF and how it is evolving
• Why CROs and Sponsors need to work together to manage the TMF successfully
• How the right eTMF enforces process coordination and collaboration
• The key features of a modern eTMF application
• How to build a shared responsibility model for the TMF

Welcome to the final episode in our series: Bringing the TMF In-House, a guide to help sponsors understand what's involved with bringing the management of the trial master file in-house and how they can do it successfully.

In our final episode, Janine and Ken talk about managing the TMF on-going and how to prepare for inspection readiness. Topics include:

• Do you need eTMF software to get inspection-ready?
• What is a reactive approach to inspection vs a readiness approach
• Tips for ongoing management of the TMF, including what to watch for

We hope you enjoyed this series and we would love to hear what you thought about the series. Drop us an email and share your thoughts!

We're continuing our series: Bringing the TMF In-House with episode 6 - Integrating Clinical Sites into the TMF Process. In this episode Ken and Janine discuss:

• The role sites play in the TMF management process
• Moving to remote monitoring and decentralized trials
• The different approaches for Sites to participate in the TMF
• The challenges and how to overcome them
• How to get started with a remote site model.