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TMF Academy

Are you hungry to learn about the Trial Master File? The reason why I do what I do is that it can get confusing. There can be a lot of grey areas. I won’t claim to be an expert or a guru but I will show you and teach you everything I know. I have an in-depth knowledge of the regulations and guidelines and a passion to educate and give you the confidence you need to be successful in working in the Trial Master File.

I am Bringing you a TMF Education Like No Other.

Everything I know is NOW AVAILABLE to you. I am making myself accessible in a way most people with my experience don’t. I will support you through the tough times and encourage you to keep going.


Online Learning

Flexible, 100% online course with 24/7 accessibility from the comfort of your home, office or anywhere else you can work on a computer with Internet access. Online courses are ideal for students who cannot fit scheduled face to face classroom meetings into their schedule or want to have schedule flexibility.

eTMF Specialist Overview

Welcome to the eTMF Specialist course, where you’ll embark on a journey to gain a comprehensive understanding of the Electronic Trial Master File (eTMF) fundamentals. This course has been thoughtfully designed to equip you with the necessary skills and knowledge to pursue an entry-level position as an eTMF Specialist. This course delves into the critical aspects of document collection, quality control, and completeness checks within the eTMF. You will learn best practices for maintaining data integrity, verifying document accuracy, and ensuring the completeness of essential trial documents.

Throughout the course, you will have the opportunity to engage in practical exercises, case studies, and assessments that simulate real-world scenarios. These hands-on activities will strengthen your skills and reinforce your understanding of eTMF management principles.


Requirements for Eligibility:

To participate in this training program, you should possess basic computer knowledge and a solid understanding of the fundamental principles of clinical research. This training is specifically designed for individuals with a background in clinical research, regulatory affairs, or a related field.

We expect participants to have a working knowledge of computer systems and be comfortable using standard software applications.

If you’re unsure whether this training is the right fit for you, we’re here to help. Please send us an email and we’ll assist you in making an informed decision.

Learning Outcomes:

  1. Demonstrate a comprehensive understanding of the regulatory requirements and guidelines governing electronic trial master file (eTMF) management in the clinical research industry.
  2. Effectively review, and approve documents within an electronic environment, adhering to standard operating procedures (SOPs) and collaborative authoring practices.
  3. Apply best practices for organizing and maintaining electronic trial master files throughout the lifecycle of a clinical trial.
  4. Utilize appropriate metadata standards and indexing techniques to ensure efficient document retrieval and cross-referencing within the eTMF.

Upon successful completion of the TMF course, you will receive a certificate, recognizing your achievement and competency in eTMF management. This certificate will validate your expertise and enhance your professional credentials in the field of clinical research.

Enrollment Cost: $1,299 USD with Medidata Rave eTMF experience (Self-paced)

Enrollment Cost: $649 USD Educational Videos only (Self-paced)

How it works:

  1. Apply below and let us know if you want the course with or without an internship.
  2. Application will be reviewed.
  3. If you are accepted, you will receive a congratulations email.
  4. Once we receive your payment, you will have access to the course within 24 hours.
  5. You will receive an email with your login information.

By submitting this form, you are consenting to receive emails from: Granular Level. You can revoke your consent to receive emails at any time. 

Frequently Asked Questions

Q. Does your course cover real-case scenarios?

A. Real Case Scenarios: We get it. Theory is great, but what really counts is how you handle the real deal. Throughout our program, you’ll tackle real-world scenarios and hands-on case studies. These aren’t just simulations – they’re your ticket to being ready for any TMF challenges out there.

Q. Do you offer an internship?

A. Internship Awesomeness: Picture this – you, applying what you’ve learned. Our partnership with Medidata is the real deal. They’re not just resume boosters; they’re where you turn knowledge into action. This is exactly what employers want…they want people with eTMF Experience!

Q. How is the course structured?

A. Structure that Works: It’s completely online and flexible. All you need is a computer and the Internet. We understand life gets busy and that’s why we are giving you 12 months to complete the program. You’ll be learning from the best in the TMF business – and that’s me! I’ve been named one of the top 5 TMF people to follow on LinkedIn.

Q. What is the difference between the 2 courses?

A. The eTMF Specialist Course w/ internship includes educational videos, quizzes and a 1-week hands on training with Medidata Rave. The eTMF Specialist course/no internship has the same videos and quizzes but does not include the eTMF hands on training.

Q. Is the internship remote?

A. Yes, it is! It’s designed to be flexible to accommodate your schedule. This means you can enhance your skills without compromising your current professional or personal responsibilities. 

Q. Do you offer payment plans?

A. Yes, we do! Email and we will work with your budget.

eTMF Specialist Alumni 

client testimonial for eTMF Specialist course