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May 17, 2016

Five Reasons Why TMF Training is Important

Providing employees with the proper training 
takes time but pays off when it's time to
prove your TMF is inspection ready.

by Sholeh Ehdaivand

President and CEO

LMK Clinical Research Consulting


Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year.  If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready. 


#1 Increases Productivity and Revenues

Experienced employees can spend significant time answering the questions of the less experienced, decreasing the productivity of your best employees. Perhaps even worse than that, poorly trained employees make more mistakes (i.e. inconsistencies), causing issues that more than likely someone else will have to clean up. Comparatively well-trained employees can reduce mistakes, prevent redundancies (less regulatory findings) and increase revenues (i.e. bringing products to market faster).


#2 Critical Component in Today’s Ever- Changing TMF Environment  

The TMF environment is ever-changing, with increased scrutiny by regulatory agencies in the United States and countries in the European Union.  After all, a carefully maintained TMF allows auditors or inspectors to effectively reconstruct the trial and helps your company draw substantial conclusions from the results. Just like in high school algebra class, it is not enough to find the right answer; in the life sciences industry, we need to “show the work.” 


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#3 Ensure TMF Consistency 

Structured TMF training ensures that employees have a consistent experience and background knowledge of the content. The consistency is particularly relevant for the TMF and how it relates to regulations, your company's basic procedures and processes. TMF employees should be aware of the expectations and procedures within your company. TMF training in these areas (at minimum) ensures that all staff members at least have exposure to the information. 


#4 Decrease TMF Employee Turnover

One thing we often see is high turnover in TMF departments. One of the most effective ways to retain employees it to provide them with access to training and development programs which creates a supportive working environment.  TMF training provides opportunities and will make employees feel appreciated, which will in turn make them feel more satisfied with their jobs.  With a higher level of satisfaction, employee moral and loyalty will increase and turnover will decrease.


#5 Navigate the TMF Process 

Like most industries, technology has altered the way we manage the TMF as many companies now choose to maintain electronic TMFs, or eTMFs, for their clinical trials. This change provides opportunities for improvement in comparison to paper TMFs and previously unforeseen challenges. 

All of these rules, regulations, and requirements may seem daunting. If you are a newer company, you may have questions:
  • How do we set up eTMFs?
  • What resources are available to us?
  • What sort of Standard Operating Procedures (SOPs) will our employees need to follow to ensure successful clinical trials?

More experienced companies may be wondering:
  • Are our SOPs optimal for an eTMF?
  • How do we switch from paper TMFs to eTMFs?
  • Are our current methods sufficient to stand up to the harsh light of a governmental audit or inspection? The answer—if your employees have not received extensive training from experienced professionals—may be “no.”

Does your company offer TMF training?  Do you see it as a way to improve opportunities in your quality department?  Place your comments below.




Sholeh Ehdaivand is president and CEO of LMK Clinical Research Consulting. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes have made her a leader and trusted expert. Her experience includes the TMF reference model subject matter expert; eTMF management; domestic and international pharmaceutical and biological clinical trials; clinical trial management; site selection; vendor relations (including CRO management); electronic document management; regulatory submissions; quality control processes and implementation; IRB communications; and regulatory inspection participation and preparation. Contact her at (704) 464-3291.






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