The trial master file is the storyteller of your clinical trial, documenting activities and decisions that are made in the pursuit of new treatments and therapies. However, if a chapter is missing, or parts of another story find their way into your TMF, it makes for very difficult reading by an inspector and the relevant health authorities. In the following presentation, Donatella Ballerini, TMF expert and Head of eTMF Services at Montrium, will be providing practical guidance on how to take a step-by-step approach to TMF process maturity and will share the path to implementing a TMF process model to help you tell better stories.
What you’ll learn:
- How to master storytelling in your TMF
- Using a step-by-step approach to reach TMF process maturity
- How to implement a TMF process model to improve storytelling