Rethink Training to Reengage TMF Stakeholders

The need for TMF training is constant. Each workday your TMF team faces a barrage of new regulatory expectations, technologies, processes, documents, therapeutic areas, and clinical trial designs. With each completed study, TMF complexity grows, and the need to learn from past successes and failures becomes increasingly critical. In an environment like this, if your TMF team isn’t growing their skills, they are falling behind.

TMF training, however, has not kept pace with the rapid advancement in TMF complexity. At present, new hires are left to read and acknowledge hundreds of pages of SOPs and work instructions without context, experienced staff face endless reminders to complete required training, many of which have little to do with their daily responsibilities, and top performers stagnate with little opportunity to grow their expertise. Instead of growing TMF knowledge and keeping up-to-date with the latest TMF advances in the industry, traditional TMF training actually discourages stakeholders from taking ownership of TMF health and takes time and resources away from achieving TMF health goals.

So how can we reverse this unsettling trend and ensure TMF training is a tool that inspires stakeholders to rethink and reengage with their TMF? Consider LMK’s best practices for building stakeholder engagement through TMF training:

Focus on the Added Value

Your TMF team is busy with the day-to-day activities required to achieve TMF health. Training that does not add value, therefore, is more harmful to TMF goals than no training at all. TMF leaders must develop a clear vision for the purpose of a training program well before deploying a training requirement to their team. Ensuring a TMF training program adds value requires foresight. The right subject matter, audience, and training format must be determined wisely. For example, a refresher course on the ALCOA+ principles might be worthwhile for less-experienced staff, but only if ALCOA+ principles are examined in a more advanced way than in the onboarding training. When your team understands and shares in the value of a training program, they are incentivized to learn because their time and effort are respected.

Encourage Independent Thinking

Because of the need to meet inflexible regulatory requirements, TMF training requirements and programs are characteristically rigid and unlikely to build real-world skills. For example, the most common TMF training includes independently reviewing and acknowledging an SOP without analysis or interaction with others. Research shows that passive training is not as effective as active learning[1]. In addition, this kind of training reinforces the preconception that there is only one way to achieve TMF health and discourages critical thinking. Experienced TMF professionals know that within a small core of nonnegotiable rules, there is a great deal of creativity needed to face even the most common TMF problems. In fact, since every clinical trial is different, an inability to think flexibly about TMF health can lead to significant compliant risks by failing to identify the need for new processes or inappropriately applying existing processes. For this reason, after the basic rules of compliant TMF management are established, more advanced training programs should give your team the chance to share and analyze their most unusual and challenging TMF problems. Exposing your team to non-standard scenarios in their training empowers your TMF stakeholders to take action when a TMF isn’t going to plan.

Build the Right Relationships

When designing a training program, it’s easy to focus on the knowledge and tools necessary to complete a process without considering the importance of the working relationships that underpin them. A critical component of TMF training is ensuring that a TMF team knows how to become a part of the study team(s) they support. As part of training, a TMF team needs to learn who to contact for information and documents. In addition to learning the responsibilities and resources provided by their coworkers, TMF staff must adapt to the working norms of their study teams to build the positive team culture necessary to TMF health. A successful TMF training program should intentionally seek to build these crucial relationships by providing the right time, setting, and tools for stakeholders to come together and unite behind shared goals.

Every TMF training program is an investment of the time and effort of both trainer and trainee, but value-added, dynamic, and relationship-based training is an investment that pays dividends. The end result is a confident and knowledgeable TMF team that has the focus, bandwidth, and engagement necessary to transform the TMF from a document repository to a powerful trial management tool.