START YOUR TMF JOURNEY THE RIGHT WAY

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.

Course:

eTMF Specialist

Description:

The eTMF Specialist course is designed to provide a comprehensive understanding of Electronic Trial Master File (eTMF) fundamentals. By successfully completing this course, you will gain the necessary skills and knowledge to pursue an entry-level eTMF Specialist position. The course will cover essential topics and equip you with practical skills that are critical to excel in this role.

Requirements:

To be eligible for this training, you should have basic computer knowledge and a working understanding of the fundamentals of clinical research. This training is suitable for individuals who have a background in clinical research, regulatory affairs, or a related field.

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. info@granularlevel.com

What You Will Learn:

  • Sponsor Trial Master File & Investigator Site File Essential Documents Collection
  • Good Clinical Practice of 1572, CVs MLs
  • Reviewing and Rejecting Documents
  • Types of TMF Metrics and Tracking of Documents
  • TMF Setup
  • TMF Inspection Readiness

Skills You Will Gain:

  • Knowledge of ICH-GCP, FDA Guidance Documentation Requirements, MHRA and the EMA Regulatory Guidance
  • TMF creation, maintenance, and closure
  • TMF Monitoring, Reporting & Compliance
  • Quality Control and Risk-Based Approach of Study TMF

Course Content:

  • Module 1: General Overview of the TMF, TMF Index, File Name Conventions, Version Control, Workflows of a document, Access to the TMF, TMF Archival
  • Module 2: Essential Documents: 1572/CVs/MLs/GCP, FDA Guidelines
  • Module 3: ALCOA-C Principles and Good Documentation Practices
  • Module 4: Audit Trails, TMF Reporting, TMF Milestones, TMF Quality Checks
  • Module 5: Inspections & Audits
  • Module 6:  Internship
  • A certificate will be issued upon successful completion of the TMF course.

Get on the wait list!