Game Changer: Standards-Focused University Launched for TMF

February 02, 2022

IAOCR is delighted to announced that LMK Clinical Research Consulting (LMK) has been awarded IAOCR Certified Academy Partners status for their pioneering of Trial Master File University (TMF University). TMF is the foundation of every clinical trial and holds critical importance to the outcome of clinical trials, yet previously there were no international standards for individuals to work by. Graduates of TMF University will be best-placed to deliver the “right first time” and “quality built in” approach required by ICH E8(R1) – quality in this area is paramount. IAOCR is committed to professionalizing the clinical research industry through independently competence-verified professionals working to international standards. TMF University provides a platform for the partnership between both organizations and a benchmark for the clinical research industry.

TMF University improves the efficiency and standards of clinical research through an independently accredited training program carrying CPE (Continuing Professional Education) points leading to Internationally Qualified TMF Professional status. The program has been specifically designed to upskill those who work in TMF and combines high-quality virtual instruction with standardized educational competency requirements. IAOCR reviewed and accredited the program to provide the international accreditation for the course and provides ongoing quality assurance and support to LMK to ensure consistency of standards, including industry-leading deliverables in terms of the training program and learner assessments.

The TMF University provides a combination of high-quality virtual instruction along with standardized educational competency requirements to prepare Internationally Qualified TMF experts. There are three learning levels within the TMF University accreditation program:

  • Discovery level courses cover the fundamental topics concerning the TMF.
  • Immersion level courses will cover essential topics that are critically important to TMF quality.
  • Mastery level courses will cover advanced topics of TMF Management, including Current Regulations, TMF Process, and TMF Metrics.

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