Your choice of eTMF system, performance metrics, quality system, and any other TMF initiative are critical, but ultimately the success of your TMF is secured through the engagement and competency of your TMF team. At LMK, we believe the most important features of your TMF are people and that innovative TMF training is as important to the future of the TMF as any technological advancement. The benefits of comprehensive TMF training extend far beyond simple inspection readiness and can unlock the true power of your team—here’s our list of the top five transformative rewards of TMF training:
Time and Treasure
An investment in TMF training pays great dividends. Junior employees without a strong foundation of TMF knowledge may occupy much of the time and expertise of senior employees. For those senior employees, gaps in knowledge result in rework. Mistakes and rework are costly, present regulatory risk and, more often than not, are completely avoidable. In fact, many organizations have created entire departments devoted to TMF remediation. How much time and money could even a modest reduction in new-hire support and rework save your team?
Versatility and Intelligence
The TMF regulatory environment is dynamic – but is your team? Regulatory expectations continually increase. Completeness, contemporaneousness, and accuracy are now expected from start-up to closeout. Already burdened with the transition from paper to electronic TMF or by continual updates to your eTMF system, your team may not have the time to monitor, analyze, and respond to the latest regulatory developments. Regular TMF training ensures your team is up-to-date and not surprised by the results of the next inspection.
Consistency and Efficiency
Every clinical trial is different, but the structure and philosophy of your organization’s TMFs should project consistency and harmony. Inconsistency between individuals, teams, and projects is a major source of rework. This inconsistency also prevents the nimble adjustment of resourcing across projects, as new team members spend precious time and energy learning the idiosyncrasies of each project’s TMF. TMF training encourages agreement across each project, sets clear expectations, and provides regulators confidence in the narrative presented in each of your organization’s TMFs.
Engagement and Empowerment
Clinical documentation department turnover across the industry is high. Providing a proper TMF onboarding experience provides new-hires the tools to achieve success and shows existing employees that their organization values investing in their skills. TMF training ensures employees feel empowered to take TMF action. Empowered employees are able to build a positive and conscientious TMF foundation, maintain a positive work culture, and possess the grit required to overcome any TMF challenge.
Direction and Intentionality
In the ever-changing TMF landscape, defining and reaching enterprise-level goals can seem impossible. Trial sites, contract research organizations, and sponsors are struggling to adapt to the modern TMF paradigm. Although modernization of the TMF has had some unforeseen challenges, modernization also provides us the chance to rewrite our TMF story. TMF training or re-training can generate new answers to the same old questions: Do our TMF processes fit our TMF needs? Are we truly inspection ready? Does our culture support the TMF we desire? TMF training provides the ideal forum for your organization to enter a new era of TMF intentionality.
LMK’s commitment to TMF education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering 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 is competency focused and designed for real world implementation. All TMF University courses are structured to build essential skills, quickly translating into a healthy TMF and a happy clinical team. For more information about the revolutionary TMF University program or to set up a complimentary consultation, contact us today.