Fundamentals of the TMF Reference Model

Description

This training will focus on how the TMF Reference Model can be utilized to improve TMF Management. Starting with the basics of the TMF Reference Model itself, the training will walk through the importance of people, process, and technology, setting up a TMF, performing QC, developing oversight approaches, and finally, surviving the dreaded inspections! Who should join this training? Those who are relatively new to TMF, those who want to learn more about the TMF Reference Model, and those who want to share experiences.

Learning Outcomes

At the end of this course, a learner will be able to:

  • Apply current regulations and guidances to the management of the TMF.
  • Describe how the TMF Reference Model is integral to the comprehensive TMF management process.
  • Apply required principles of the TMF Reference Model to understand where the records of the TMF are managed during and after the conduct of the study.
  • Design basic TMF management processes based on the TMF Reference Model such as TMF Quality Control, TMF Index, TMF Plan, and TMF Oversight.

Continuing Education Units (CEUs)

The learner must receive a score of 80% or higher on the Final Assessment to earn 0.8 CEUs.


Course Type

Licensed
Private
Public
Virtual Classroom

Course Length

1 Day