TMF Summit EU
It turns out that TMF not only stands for Trial Master File but also Too Much Fun and Too Many Friends! I was fortunate to attend the Fierce EU TMF Summit in person for the first time since 2019, and I was able to catch up with so many friends and industry colleagues.
With the theme “Improve Your TMF Quality,” there was an abundance of knowledge sharing and case studies on how organizations are addressing quality. The workshop day gave attendees a deeper, hands-on approach to learning about achieving optimal quality, and workshops included How to Win Friends and Influence People, Managing the TMF, Developing a Risk-Based Approach, Defining TMF Metrics as Oversight on TMF Performance, and Aligning TMF Vendor Processes.
There were some excellent presentations and lively discussions that covered many aspects of a quality-driven TMF. Here are my top five takeaways from the EU TMF Summit.
- Andrew Fisher, Lead Senior GCP Inspector with the Medicines and Healthcare products Regulatory Agency (MHRA), said there has been significant improvement in eTMF systems in recent years, with no recent critical findings from them! This is excellent news as it gives us all reassurance that we are going in the right direction with eTMF adoption.
- ICH E6 R3 will need to include updates to reflect the increased use of the TMF Reference Model for a checklist of required TMF documents and reliance on electronic systems such as eTMF. The tables in sections 8.2–8.4 are seen as paper-document-focused and inconsistent, and electronic systems should have guidance included for system and signature validation.
- There is still a lot of confusion about how to manage email correspondence in the TMF. Many attendees were not aware of the brilliant guidance from the TMF Reference Model on e-mail communications in clinical studies. The Reference Model gives some advice on the management of emails that enable evaluation of the conduct of the study; key decisions made during the study; the integrity of the study data; and compliance of the investigator, sponsor, and monitor with the standards of GCP.
- Attendees were keen to learn more about eTMF system audit trails to demonstrate oversight, completeness, and accuracy of the TMF systems in place. Audit trails can be used to identify missing data, detect signs of data manipulation, identify abnormal/outlier data, and detect unauthorized accesses and device or system malfunctions. This is a subject I presented at the Fierce US TMF Summit in 2021.
- Educate, educate, educate! Embedding TMF accountability into goals, objectives, and training on a dedicated, ongoing TMF health program is imperative for maintaining a high-quality and contemporaneous TMF.
Look out for future TMF Summits and join the TMF community….