Turn your team into a lean, mean, TMF machine
We offer TMF training and education for the bootstrappers, the go-getters, and the trial master file leaders of tomorrow. Expert-led and backed by years of experience, our programs will help you gain the internal skills you need to successfully scale TMF excellence at your organization.
Whether you’re just starting out in the world of trial master file (TMF) or whether you’ve got several years of experience under your belt, our TMF trainers will be able to provide comprehensive learning plans and courses customized to your unique level of experience and organizational needs. Craft the TMF environment that will breed inspection readiness, starting with the people behind the clinical trials.
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Our TMF Maturity training packages will give your team the independence and know-how to tackle the complex challenges of the TMF management environment. Carefully engineered over three core levels, TMF Maturity provides the training your teams need to improve their knowledge of trial master file management, no matter their starting point.
Our TMF Maturity Essentials package will enable you to hit the ground running with your eTMF system or the beginnings of your new TMF process. We’ll get everyone on your team up to speed about trial master file processes, functions, clinical trial documentation best practices, and regulatory requirements. Participants will also get the chance to gain hands-on experience in our interactive workshops that pair perfectly with our TMF training courses.
This session will help your team members understand the importance of the TMF. You will learn the purpose of ICH GCP and its relationship with TMF in terms of the components, aspects, timing, and the difference with ISF.
— ICH GCP & TMF
— Who is responsible for TMF
— TMF Locations
— TMF Format
— TMF Index
— TMF Timing
— TMF vs ISF
— The Important of TMF
The eTMF Plan is the fundamental document of all clinical trials. Inthis session, trainees will learn its importance and what it really is. Youwill come away from it knowing when to establish the eTMF Plan, who thedifferent stakeholders are, and allof the best practices to support it.
— What is a TMF Plan?
— The importance of a TMF Plan
— The benefits of a TMF plan
— When to establish a TMF plan
— TMF plan stakeholders
— What should a TMF plan cover?
— TMF plan best practices
— TMF plan for inspection readiness
— Create and customize a TMF Plan one of your studies
Trainees will be introduced to the different TMF index options. The TMF Reference Model will be discussed in detail, and you will understand its structure, organization, and components. By the end of the training, you will know how to create and maintain a TMF index and file challenging document types.
— Introduction to TMF Index
— TMF Index options
— The TMF Reference Model
— Customizing the TMF Reference Model
— TMF Index Procedures
— TMF Index Best Practices
— Customize TMF index spreadsheet for study and configure system
Ensuring an inspection-ready TMF starts with quality documentation. Trainees will understand the meaning and will be able to perform Content, Non-Content, and Post Scan QC. You will also understand what a certified copy is and learn how to document QC evidence.
— TMF Document QC
— TMF Documents Non-Content QC
— Good Documentation Practices
— Post Scan QC
— Certified Copies
— TMF QC Evidence
— Perform a Quality Check within your eTMF system side by side with your team
Our TMF Maturity Intermediate package is perfect for those who already have fundamental knowledge of the trial master file and who are looking to expand their skill set. We’ll cover quality assurance practices relating to TMF documents, data integrity, compliance, and oversight. The course will also include interactive workshops intended to cement what was learned and provide participants an opportunity to see the theory in action.
Sponsors are ultimately responsible for overseeing the TMF. Trainees will understand why oversight is so important and how to put processes in place to ensure it is performed and documented.
— The Outsourcing Model
— What is Oversight?
— TMF as an Oversight Tool
— Processes for TMF Oversight
— Importance of the TMF Plan for Oversight
— Quality Agreements
— Defined Metrics
— Oversight for Inspections
Trainees will learn the true difference between Quality Check and Quality Control. Then, with this as a baseline, we will dive deeper into the relevance of implementing and performing Quality Control of your TMF.
— Document QC Vs Quality Control
— The Importance of TMF QC
— How to Ensure TMF QC
— Review an existing eTMF Quality Control report for an existing study
Make data integrity a reflex—not an afterthought. This training will go through the ins and outs of data integrity, from its meaning to the ALCOA+ principles and beyond. You will come away knowing how to comply with the regulations and avoid data integrity issues that could have serious consequences and cause potential harm.
— The meaning of Data Integrity
— The relevance of Data Integrity
— How to ensure TMF Data Integrity
— ALCOA Principles
— Data Integrity Regulations & Guidelines
— Data Integrity Issues
— The Future of Data Integrity
There is no eTMF without solid processes behind it. This training will cover the processes and activities through a trial lifecycle. You will understand the tools needed to check compliance with your own TMF processes and decipher which TMF management model you fit into.
— TMF Process as the Foundation
— TMF Process & Technology
— TMF Study Lifecycle
— TMF Certified Copy
— TMF Training Process
— Check Compliance
— TMF Management Models
— Perform a TMF Maturity Assessment of your teams current environment
Inspection readiness starts with understanding the regulations impacting your TMF. You will leave this training understanding how to implement regulatory changes into your organization and TMF processes.
— Why TMF for Inspections?
— Regulatory Agencies
— TMF Impact
— Implement Regulatory Requirements into TMF
— Adapting to change in regulatory guidance
— Regulations and Inspections
— Other regulations
— Review applicable regulations to your organization and align to Montriums TMF Inspection Readiness Framework
Our TMF Maturity Advanced package offers more than just a deep-dive into advanced trial master file concepts—it gives organizations the chance to build and hone the skills necessary to achieve trial master file excellence. We’ll provide your team with all the necessary theory and experience to create a comprehensive understanding of risk-based approaches, inspection readiness, metrics, KPIs, storyboarding, and quality by design.
What is risk and what are the risks surrounding your TMF? Understanding this helps you create more efficient TMF processes through a risk-based approach. During this training, you’ll understand how to apply a RBA to your TMF and what challenges you might face along the way.
— What is Risk?
— Benefits of Risk Based Approach
— Risk Based Approach applied to eTMF
— Challenges of Risk Based Approach
Using storyboards to prepare for an inspection could be the difference between a good inspection experience and a great one. We will guide you through the basics of what they are, when to use them, and how to develop them. Then,when it comes to really needing it, you’ll know how to use storyboards during an inspection.
— Storyboard Definition
— Storyboard Purpose
— How to Develop a TMF Storyboard
— Who, Where & When to Storyboard
— Storyboards & Inspections
— TMF Storyboard Challenges
— Draft a clinical study storyboard in preparation for an inspection
Inspection readiness is a state of being. This training will help you understand what it really means and why it’s important. Know how to plan for inspections and the tools you’ll need to ensure you pass successfully,especially in the world of remote inspections.
— The Meaning of Inspection Readiness
— The Importance of Inspection Readiness
— Planning for Inspection Readiness
— Allies to Guarantee Inspection Readiness
— Remote Inspections
— Review common inspection questions and guidance on appropriate answers
Building quality into the design of clinical studies is now are gulatory requirement. Trainees will understand what quality by design is and how to implement it. This session will finish up by going through the different levels of the TMF Maturity Model.
— The Meaning of Quality in Clinical Trials
— QbD Implementation
— QbD Applied to TMF
— Maturity Models for TMF Quality
— TMF QbD Case Study
— Customize a part of your TMF management process with a QbD approach
TMFs don’t just hold documents, they hold data that can help drive processes and decision-making. In this training, we’ll teach you how to use metrics and KPIs to improve TMF management and inspection readiness.
— What are Metrics?
— Why Measure the TMF?
— What Metrics to Measure?
— Industry References
— Key Performance Indicators (KPIs)
— Metrics Program Implementation
— How to Apply Metrics & KPIs toT MF Management?
— Metrics to Agile TMF
— Generate and review a metrics report for a study and identify areas of focus
Kick off your journey to TMF Maturity today and gain access to a comprehensive library of templates and tools
eTMF plan template
eTMF management SOP
Work instruction for trial setup & system admin
Work instruction for document lifecycle management
Standard eTMF business rules
TMF Ddocument QC checklist
eTMF index template
Regulatory resource package
TMF maturity model
Email & communication guidance
Sample TMF QC report
Inspection readiness framework
Case studies & reference articles
Inspection readiness checklist
Customized QbD process
TMF storyboard for a study
TMF metrics report for a study
TMF mock inspection tools
Catalyze the knowledge you acquire
Most TMF training programs arm you with the know-how, but don't provide a path to actually using it in the real-world. Our workshops bring your entire team together to actually implement what they've learned in the courses.
Made with you in mind
Our TMF courses and workshops have been designed specifically for scaling clinical trial teams, created with and backed by years of industry-specific experience in trial master file management.
Chart your own course
We offer the opportunity to modify and customize your learning experience to suit your specific objectives and needs.
Learn on your terms
Our courses and workshops can be delivered 100% remotely, granting you the flexibility to learn where and when it’s convenient for your teams.
Add to your mantel
We provide all successful participants with a certificate of completion to demonstrate that they have passed the courses and the level of TMF knowledge they now have.
Access to our experts
Our team will be on-hand throughout the entirety of the project, providing you with non-stop support as you progress in your TMF maturity journey.
When it comes to the trial master file, nothing will help you understand concepts, processes, and tools better than getting your hands a little dirty.
We offer a variety of skill-building workshops that give your team the opportunity to build practical experience in everything from the TMF reference model, TMF essential documents, and good clinical practice (ICH GCP) to quality assurance, TMF health checks, and so much more.
Our workshops are paired with comprehensive courses and delivered remotely, allowing your team to strengthen their TMF skills in the environment that works best for them.
Need a refresher on essential documents? Want to deepen your understanding of TMF metrics? Have a specific TMF-related topic that you’d like to explore further? You’ve come to the right place.
We provide on-demand training to accommodate the unique composition of each clinical trial team, allowing you to zero in your learning on the areas in which you want to want to improve the most.
Our on-demand training is supported by a state-of-the-art e-learning platform, offering an immersive experience that prioritizes your freedom to learn in the way that’s right for you.
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