TMF University: Designed for Real-World Implementation

LMK’s TMF University program offers a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. TMF University allows your entire team to benefit from the collective experience of LMK’s TMF experts and may even inspire your team to take a new perspective on the TMF.

Of course, the TMF plan, QC plan, and your regulatory strategy all depend on the foundation provided by a functional QC cycle. Regardless of your experience, TMF University and our TMF experts will guide your team towards the implementation of a QC cycle that continually verifies the condition of the TMF against the expectations captured in your TMF plan. Not just a simple list of documents, the output of your TMF QC cycle will be a focused and actionable path to success.

Our TMF University Catalog

Is your company or team new to the TMF? Our novice level courses can guide your team through the basics of document recognition, document storage, and the basic principles of TMF QC. Your TMF novices will have the opportunity to handle simulated regulatory documents, building context and introducing the basic interdependencies between documents in the TMF. TMF University is competency focused: courses are structured to build skills quickly, priming your new team members to make meaningful contributions to the TMF as quickly and efficiently as possible. By ensuring your team achieves an elementary level of TMF knowledge, you’ll quickly see a surge in the health of your TMF.

TMF Overview (TMFIN01)

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)

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)

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

Document Quality Control (TMFDC01)

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

Inspection Readiness (TMFIR01)

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

TMF Quality Control (TMFQC01)

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

Is your team familiar with the basics of the TMF but failing to achieve their full TMF potential? Our intermediate courses examine the nuances of TMF indexing, filing structure, and in-depth QC processes, so your team can confidently tailor their TMF to fit the unique needs of any trial. Our advanced courses provide the tools for TMF decisionmakers to confidently interpret the regulation which underpins the TMF, prepare for a regulatory submission, achieve inspection readiness from the outset of a trial, and harness the power of the data with the TMF. Ensuring your trial’s leaders are TMF experts reduces the overall regulatory risk of the trial and inspires confidence across the entire team.

Good Clinical Documentation Practices (TMFGO02)

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)

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)

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)

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

SOP Mapping (TMFSM02)

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

eTMF Best Practices (TMFBP02)

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

Does your team struggle to produce useful TMF Plans and QC Plans? Through the continued development of both foundational skills and more advanced concepts, TMF University provides TMF leaders the know-how and confidence to produced useful and actionable plans for the TMF. For example, our courses on filing structure and document indexing can help your team create a QC plan that anticipates risk associated with potential high-volume filing tasks or study-specific document types. Our courses on inspection readiness and current regulatory requirements allows you to view your TMF through the lens of an auditor or inspector to prevent negative findings before they occur. Incorporating this perspective into each iteration of the TMF Plan ensures lessons-learned and process improvements are continually integrated into day to day trial conduct.

Current Regulations (TMFCR03)

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)

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)

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)

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)

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)

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.

TMF University is your premier opportunity to connect TMF knowledge with TMF action. By offering courses personalized to all levels of experiences, all organization sizes, and all stages in the lifecycle of the TMF, we empower your team to turn TMF drudgery into TMF mastery—transforming your TMF into a prospective management tool and competitive advantage.

Contact our TMF Professionals to train your TMF ResourcesOur unique training program is designed for all levels from novice learners to experts covering a range of TMF topics in 16 modules. TMF University can provide the foundational knowledge required to understand the TMF.