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

• Apply current regulations and guidances to the management of the TMF.

• Describe how the CDISC 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.

After purchasing a training, you will automatically receive a Confirmation Email with the following:

• an order number
• link to the CDISC Learning Management System (LMS)

You can immediately access the online training materials in the LMS.

Within 24 hours, you will be assigned to your specific seminar event.

You will receive a Training Booking Confirmation Email with the following:

• event details 
• an iCal attachment

Please contact us if you do not receive these emails within 24 hours.

• It was very useful that the instructors had open sessions for groups to work on open-ended exercises with no true solution (but very potentially real examples, as there often isn't a singular correct answer). It was interesting to see the various responses and thought processes from other experts in the industry. I also really enjoyed learning about the TMF Reference model and its relation to metrics. 
  

• The history and background of the TMF reference model was very helpful to provide some grounding on the topic.  ​

• The interactive activities were a plus, as well as the instructor's answers to the questions raised during the presentations. ​

• The course contained a wealth of information including resources to the available references regarding TMF management. I really enjoyed applying what was discussed during the group exercises. It was also a wonderful networking opportunity.

• As someone with little TMF experience, the training made the model far less overwhelming and easier to understand the various pieces. ​

• The collaborative workshops and discussions allowed for debate about real-life scenarios and solutions.​

• The instructor spoke from deep knowledge on the subject and gave good answers to all the asked questions. ​

• The sessions were interactive and gave great room for discussions. As someone relatively new to TMF in an academic setting, the review of the reference model, the regulations around it, and how to manage and implement the model was exactly what I needed. I have so many thoughts and ideas to take back to my team to improve our TMF oversight. This was an EXCELLENT course that would encourage anyone involved in TMF to take!!

Course Education Units (CEUs)

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