TMF University

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.

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.

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.

TMF University Catalog

Novice Courses

  • TMF Overview
  • TMF Storage
  • Document Recognition
  • Document Quality Control
  • TMF Quality Control
  • Inspection Readiness

Intermediate Courses

  • Good Clinical Documentation Practices
  • TMF Indexing
  • TMF Filing Taxonomy
  • SOP Mapping
  • eTMF Systems Overview
  • eTMF Best Practices

Advanced Courses

  • Current Regulations
  • TMF Quality Case Studies
  • TMF Filing Taxonomy Deep Dive
  • TMF Metrics
  • TMF QC Deep Dive
  • TMF Process Best Practices