In the “Guidelines, Regulations, and Tools Related to Trial Master File” course, you will learn based on which regulations we work with clinical documentation. How the approach to TMF has changed over time, and what conclusions have various legislation has ultimately reached about document management.

Well, because that documentation is not an inseparable part of clinical research we know, but basically what legal basis do we have for it? This is what you will learn about in the course.

With the basic idea coming out of the regulations being the proper care and oversight of the TMF with constant preparation for inspections, the course will also discuss the tools required for this purpose. You will learn how to properly set up the TMF not only in the study, but also in the entire organization using the TMF Reference Model, and how the Expected Document List or milestones help us.

After completing this course, you will be able to properly oversee and monitor TMF Completeness, TMF Timeliness, and TMF Quality. You will know how to use available KPIs, and metrics, and which reports to use when evaluating TMF Health at different levels – from the site to the study, to entire departments or the organization.

Do you want to manage TMF effectively and be TMF Inspection Ready at all times, but don’t quite know how? This course is for you!