Mastering TMF Management: A Practical Guide to a Risk-Based Approach

Reasons to attend

As clinical trials grow more complex, the Trial Master File (TMF) is no longer just a repository of essential documents – it is a living reflection of trial conduct and regulatory compliance. Transitioning to electronic TMFs (eTMFs) has accelerated the need for risk-based approaches to oversight, inspection readiness, and long-term quality.

ECCRT and Montrium have partnered to design this specialised course, building on Montrium’s TMF Maturity Training framework. This course provides an overview of the risk-based approach (RBA) as applied to Trial Master File (TMF) management. It defines risk and hazard and outlines a framework for building a risk-based TMF management framework using a 5-step approach.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course schedule

We provide this course as a 3 hour webinar. 

Course Description

The Trial Master File (TMF) has always been a cornerstone of clinical trial operations, but with the transition to electronic TMFs (eTMFs), it has become much more than a static compliance archive. An eTMF is now a dynamic system that reflects trial quality, oversight, and regulatory compliance in real time. This shift brings new challenges: how can organisations manage eTMFs in a truly risk-based way?

This focused half-day training, developed in collaboration with Montrium, provides participants with a clear and practical framework for applying risk-based approaches to eTMF oversight. Rather than covering TMF basics, the course dives straight into the key risks that impact eTMF quality, data integrity, and inspection readiness—and how to address them effectively.

The course begins by establishing a foundational understanding of what constitutes a risk versus a hazard, using practical examples. It then delves into the benefits and challenges of applying a risk-based approach to TMF. The training outlines a structured process for risk management, including steps for identification, evaluation, control, communication, and review of risks. The course also addresses the different types of TMF documents, referencing the CDISC TMF Reference Model as a starting point. The session combines targeted expert input with interactive discussion and real-world case studies, enabling participants to immediately connect theory with practice.

This training is the ideal next step for professionals who already understand TMF fundamentals (covered in ECCRT’s Managing the Trial Master File and Basics of Clinical Trial Systems course) and now want to elevate their expertise with a risk-based approach to eTMF management and staying compliant with regulatory requirements.

By the end of the course, attendees will leave with practical tools and actionable strategies to help their organisations achieve higher TMF maturity and support better inspection readiness.