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Highlights from the US TMF Summit 2023

Gillian Gittens, Director of eClinical Strategy & Solutions

TMF Expert Insights

Thursday, April 27, 2023 | 8:05 AM

TMF Summit 2

Last month, in the middle of the NCAA basketball tournament “March Madness,” TransPerfect’s Trial Interactive Life Sciences team attended the Fierce US TMF Summit, the first fully face-to-face US event since 2020. And, once again, I was able to catch up with Too Many Friends and colleagues.  

The March Madness theme made it to the Summit as well, as my fellow co-chairs and I took on the role of “basketball coaches” to facilitate a mock inspection exercise. This enabled attendees to work together in a simulation based on a real-life inspection scenario. It was a great, enjoyable way to work in teams and come up with solutions! It was amazing to watch and coach the teams and then have them present their corrective and preventative actions to a group of judges, who selected a winner for the best team solution.  

With the themes of boosting internal & external collaboration and eTMF processes and technology, teams worked together to achieve optimum quality control and streamline TMF operations and technology. 

Here are my top three takeaways from the US TMF Summit…   

When the FDA speaks, we listen 

The FDA inspector reiterated what we already knew: If it wasn’t documented, it didn't happen!  

He also said that oversight is only a problem if you didn't do it, and any oversight would be thoroughly scrutinized if there were any problems! I think many in our industry still find it hard to document oversight in the TMF, as they are not sure what is required. He went on to give us some insight into how the FDA inspects eTMFs by directly accessing the sponsor’s computer systems where the sponsor is agreeable: 

  • Access should be read-only but is not limited in view of relevant data. 
  • Sponsors must provide training.  
  • Assistance with the system should be provided throughout the inspection. 
  • Inspectors can complete access forms but cannot sign them! 

We love to learn about regulatory inspections 

FDA, EMA, MHRA, PMDA—it doesn’t matter. People soak up any information on inspections, especially what our other TMF colleagues have experienced. The message from the Summit was that we are all in this together—new and old TMF folks—and we are all still learning. The inspection simulation, which so many enjoyed participating in, showed us what we can learn by working together. 

Working with internal functional areas is still a challenge 

While the TMF is the center of the universe for me and my fellow TMF-ers, it still seems to be less of a priority for other functional areas. It’s important to implement open collaboration and communication right from the start, especially when moving from a paper-based TMF to an electronic one. It’s important to include functional area involvement when bridging any process gaps; create a knowledge center to share TMF-related information; and develop dedicated, cross-functional operations teams to translate the business to the system and support study teams. 

If this gives you a flavor of what was discussed at the Summit, and you like the taste, make sure you attend the next one! 

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