Top 4 Ways TMF Corporate Education Can Revitalize Your TMF

June 1, 2022

On Thursday, June 9th, at 1 PM Eastern Time, Jackie Morrill, Executive Director at LMK Clinical Research Consulting, will share LMK’s most powerful tool for jumpstarting TMF teams. We are, of course, talking about the upcoming TMF Corporate Education Town Hall, where Morill will review LMK’s extensive portfolio of non-accredited corporate education courses. LMK’s Corporate Education Program is designed to tackle the TMF training and educational needs of corporate clients, both large and small, and is designed for all levels of experience, from novice to experts. Most importantly, each course can be customized by LMK’s TMF consultants to produce a learning experience relevant to any company’s real-world TMF environment—even using your current TMF system, processes, and document templates.

Still not sure if LMK’s TMF Corporate Education Program is right for your organization? Below are the top four ways, according to our clients, that LMK’s TMF Corporate Education Program has revitalized their TMF teams.

Target What Matters

Is the industry standard ‘read and acknowledge’ training failing to connect with your TMF stakeholders? Moreover, even if your learners are retaining their read and acknowledge training, does the content of this training meet your team’s needs? Far too often, LMK’s TMF consultants encounter TMF training programs that focus solely on operating an eTMF platform, are irrelevant to an organization’s current processes, or fail to address trial-specific topics that are essential to TMF health.

LMK’s TMF Corporate Education Program is the antithesis of read and acknowledge training. After consulting with your TMF decision makers, LMK’s TMF consultants will create a custom-tailored training program based on the real world demands of your business. LMK’s TMF experts are system-agnostic, meaning they can produce training based on your eTMF system, regardless of the platform. They can even develop training materials based on your specific regulatory documents, projects, or protocols. All you need to do is identify the skills you would like your team to learn, knowledge gaps you would like to close, or deficiencies you would like to mitigate, and LMK’s experts will develop the ideal training solution based on your exact requirements. LMK’s experts will even give you to the tools to check your team’s understanding and to quantitively measure the impact on your TMF moving forward.

Attain Cross Functional Engagement

Whether document filing and indexing is the responsibility of the document owner, a dedicated TMF team, or a service provider, the sponsor’s management has ultimate responsibility for the quality of the TMF. This responsibility cannot be delegated away. At minimum, the sponsor, including the sponsor’s experts in functional area groups, such as data management, monitoring, and medical writing, must all take an active role in determining what essential documents are needed for the TMF. It is not fair or reasonable for clinical operations professionals or TMF experts to be expected to know every essential document needed in the TMF. It is a team effort that relies on the democratization of knowledge across an organization.

LMK’s TMF Corporate Education Program fosters cross functional TMF engagement through two primary means:

  1. Ensuring that functional area experts who do not frequently file TMF documents have the foundational knowledge necessary to use the eTMF and to identify which of their documents must be filed in the TMF
  2. Providing clinical operations and TMF specialists with the knowledge, tools, and confidence they need to effectively interact with other functional areas regarding TMF quality, even if they are not an expert in a certain discipline

TMF training also creates a low-stakes environment for TMF and clinical operations professionals to come together with functional area experts and brainstorm effective processes and means of communication. When healthy TMF relationships are forged across functional areas, subject matter experts will find their TMF responsibilities are manageable and TMF specialists will find the narrative in their TMF unified, coherent, and complete.

Reset TMF Culture

Who is responsible for the health of your TMF? Maybe you are not sure how to answer this question. Worse yet, perhaps your team believes TMF health is solely the responsibility of clinical operations or the TMF group. Unfortunately, modern best-practices and regulatory expectations require a meaningful commitment to TMF quality from all functional groups, regardless of what kind of document processing model your organization employs. The modern TMF is simply too complex to be delegated away to administrators or service providers.

Clients who participate in LMK’s TMF Corporate Education Program often see TMF quality improvements well beyond the scope of topics covered in their individual program. At LMK, we attribute the overall beneficial effect of specialized TMF training to its ability to reset TMF culture. Investment in quality TMF training for your employees sends the message that you value their growth, their expertise, and TMF quality. It also dispels the harmful notion that TMF professionals are document reviewers and that the TMF management is an administrative task for the inexperienced. Successful TMF professionals must have advanced skills in project management and clinical operations oversight to achieve the ever-increasing expectations of regulators. This culture of learning must be intentionally cultivated and modeled by leadership that values and rewards continual improvement.

Inspire TMF Leadership

While LMK’s TMF Corporate Education Program is designed to address the most common and urgent TMF problems of the present, its greatest transformative potential will only be fully realized through the TMF leadership of tomorrow. If TMF learners are given the opportunity to develop the skills and TMF-centric culture fostered by LMK’s TMF Corporate Education Program, we are confident this new class of interdisciplinary, well-connected, and inspired TMF champions will take the reins of the future of clinical operations.

How will this next generation of TMF leadership change the TMF? By uniting the full potential of eTMF technology with the hyper connected life sciences landscape that has already begun to take shape. These outstanding TMF professionals will confidently refocus our clinical documentation effort on what matters most through custom-designed metrics. They will bring diverse and isolated experts together to solve interdisciplinary problems once thought unsolvable. They will strengthen sponsor oversight by automating the mundane, by bringing together new data streams, and by elucidating new and valuable insights that have been hidden in the TMF all along.

All of this, though, depends on your investment in your present TMF team—which is why we invite you to reassess your organization’s TMF education program and add LMK’s virtual TMF Corporate Education Town Hall on June 9th to your calendar. We look forward to discussing your vision for the future of your TMF team.