TMF University

What is TMF University?

Our unique training program is designed in individual modules. Modules can be mixed and matched among the different experience (novice, intermediate, and advanced) levels. Each module contains the following: 

- Presentation

- Hands-On Practice

- Case Studies

- Knowledge Check

 

Why Choose TMF University? 

From novice to expert, LMK's full suite of TMF training modules can provide the foundational knowledge required to understand the TMF. The training ranges from regulatory agencies and ICH definitions of the TMF, proper storage (i.e paper, electronic or a hybrid system), to how to effectively report TMF health, and continuous inspection readiness throughout the duration of a clinical trial.

 

*Each module is approximately 2 hours
*Attendees will receive all training materials & certification of completion
*Customization Available
 

Our Instructors

Please use the sliders below by hovering the mouse over the slides to reveal how a course here at TMF University can help address your TMF needs.

 

TMF University Catalog

      Novice Courses

TMF Overview (TMFIN01)

Do you want to better understand the importance of the TMF and how TMF quality can affect the outcome of your study?

Get introduced to the TMF. Learn why it is so critical to the success of your trial, and how Regulators influence TMF management practices.

 

TMF Storage (TMFST01)

Do you struggle with what and how documents and content should be stored in the TMF?

Learn about TMF storage practices and options: electronic, paper, and a combination or hybrid of both. Understand the Regulators’ view of TMF storage.

 

Document Recognition (TMFRG01)

Are you looking to expand your clinical trial knowledge and better understand which documents get filed in the TMF and when?

Learn to recognize TMF documents and what documents to expect in the TMF over the duration of the study.

Document Quality Control (TMFDC01)

Are your documents complete and accurate prior to filing them in the TMF?

Learn the importance of performing consistent and timely document QC. Get hands-on practice QCing documents using proven processes and tools.

Inspection Readiness (TMFIR01)

When you receive an inspection notification from a regulatory agency, are you panicked or prepared?

Take an in-depth look at preparing for an inspection. Get prepared and stay that way.

TMF Quality Control (TMFQC01)

Do you want to avoid an uncomfortable inspection and possible findings?

Learn about best practices for TMF QC. Explore 3 ways -prospective, retrospective and oversight- to perform TMF QC and ensure continuous inspection readiness.

Intermediate Courses

Good Clinical Documentation Practices (TMFGO02)

Do you understand why the TMF is the foundation of a clinical trial?

Build upon your TMF content knowledge. Learn how to create a strong TMF foundation and ensure all required documents are complete and filed appropriately.

 

TMF Indexing (TMFIN02)

Does your indexing system ensure documents are appropriately sorted and filed?

Learn which documents need to be filed in the TMF and how to index them properly. Confirm your filing practices are consistent and follow best practice principles.

 

TMF Filing Taxonomy (TMFFT02)

Does your TMF table of contents (TOC) let you know what documents to expect throughout the life of your study?

Learn why establishing a TOC for expected documents is imperative to TMF quality. Explore best practices and the pros and cons of common TMF filing structures.

eTMF Systems Overview (TMFeT02)

Are you thinking about moving to an eTMF and unsure of which eTMF system would be right for your company?

Explore the many eTMF system options. Look at functionality and decide which system Is right for your company.

SOP Mapping (TMFSM02)

Are your SOPs mapped to your TMF filing structure?

Learn why mapping is so important, and how mapping appropriately can ensure TMF success.

eTMF Best Practices (TMFBP02)

Do you understand your new eTMF system and all of its different functionality?

Get the most value out of your eTMF. Through hands-on training, Learn what your new eTMF systems can do - Its functionality may surprise you

Advanced Courses

Current Regulations (TMFCR03)

Are you struggling to keep up withthe ever-changing TMF guidance and regulations?

Get up to speed with the current TMF regulations (FDA, MHRA, EMA, and ICH). Learn how to stay informed and up-to-date.

 

TMF Filing Taxonomy Deep Dive  (TMFFT03)

Are you confident that you are using the right TMF filing taxonomy; one that meets your organization's specific needs?

Learn about the many available filing taxonomies. Take a deep dive into the one your company is using: perform periodical review of the filing structure and learn about best practices for maintaining an up-to-date model.

 

TMF Quality Case Studies  (TMFCS03)

Are you looking for ways to improve TMF quality?

Explore different types of TMF quality issues—expected and unexpected—you may encounter within your TMF. Apply best practices and receive valuable tools to address these issues.

TMF Metrics (TMFMT03)

Do you have a metrics program in place to measure TMF health?

Learn about the importance of measuring TMF health. Explore how to develop and maintain an effective TMF metrics program including the development of key performance indicators and various escalation pathways for non-compliant documents and/or studies.

TMF QC Deep Dive (TMFQC03)

Are you ready to implement a comprehensive TMFQC program that effectively measures TMF health?

Take a deeper dive into TMF QC: prospective, retrospective, and oversight. Learn how to implement an effective TMF QC program that best meets your needs.

TMF Process Best Practices  (TMFBP03)

Do you have an eTMF system, but are still utilizing a paper process?

Explore best practices in developing, managing, and monitoring an eTMF process that is regulatory compliant for audits and inspections. Learn the importance of aligning your people, processes, and technology to ensure TMF success.

Contact us today at tmfuniversity@lmkclinicalresearch.com to speak with one of our university instructors to develop a customized training program to meet your individual needs.