Dec 11, 2020
How can clinical trial organizations achieve TMF excellence? That’s one of the important issues discussed in Sholeh Ehdaivand’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Ehdaivand, President and CEO of LMK Clinical Research Consulting, a certified woman-owned TMF consulting company, notes that the TMF (Trial Master File) is the collection of documents and data associated with the clinical trial. Often referred to as “the story of the clinical trial,” it is designed to serve the needs of all stakeholders, including sponsors, sites, regulators, and auditors. The TMF serves as confirmation that participant rights have been protected and that the data are reliable, Ehdaivand says. While that may seem like a simple concept, she adds, not everyone understands what is actually included in the TMF. The TMF is not a “document dump,” but should be an active file containing all relevant and, especially in 2020, applicable data, according to Ehdaivand. Her company’s motto is “if it isn’t written down, it didn’t happen.” She also notes that the TMF should be compiled and organized in a timely manner and in compliance with regulations from governing authorities. She explains how the organization of the documents in the TMF is just as important as the documents themselves. Sullivan and Ehdaivand discuss LMK’s launch of TMF University in January 2021, the first and only internationally accredited TMF training program in the industry. The curriculum includes completion required assessments to ensure that students truly learned and fully understand the components of an inspection-ready TMF. The certification program is designed to elevate the importance of the TMF so that stakeholders will not just look at it as a place where “documents go to die.” There are three learning levels within the TMF University accreditation program: Discovery level, which covers the fundamental topics concerning the TMF; Immersion level, which covers essential topics that are critically important to TMF quality; and Mastery level, which covers advanced topics of TMF Management. Completion of learning levels one and two (six courses) along with the satisfactory completion of the required assessments will earn students the internationally recognized status and credentials of Qualified TMF Associate, while the completion of all three learning levels (9 courses) and assessments will earn students the internationally recognized status and credentials of Qualified TMF Manager.