Highlights from the TMF Summit 2022 - Arkivum

eTMF & GCP Data / 10 May, 2022

Highlights from the TMF Summit 2022

Last week I was fortunate enough to attend the TMF Summit 2022 in New Orleans. The event was three days’ worth of excellent and interesting workshops, discussions and presentations, including one from Arkivum’s very own Rob Jones on the transfer of data from CRO to sponsor at the end of a clinical trial. 

While I don’t have enough space here to cover everything that came up at the event, I wanted to take the opportunity to share some of my key takeaways from the conference. 

What to do with your data at the end of a trial? 

This was the focus of Rob’s session, but also something that came up in many of the discussions we had on the Arkivum booth.  

Many sponsors have limited plans in place to effectively archive their data at the end of the trial and instead opt to keep it within their TMF system. While this approach may make sense in the short term, it leaves the data at risk of corruption, loss or obsolescence, and is often not cost effective. 

 Planning the management of your data post-trial as early as possible will:  

  • Support compliance with regulations 
  • Ensure easy access for future use  
  • Save your organisation money 

Is there a knowledge gap on TMF regulations? 

This was a reoccurring theme across several of the sessions. It was perhaps best illustrated during the session on EU regulation 536/2014 where a poll of the audience highlighted that only 1 in 4 had fully assessed the impact of the new regulation which came into effect in January of this year. 

Whilst regulations might not be the most exciting of topics and can be vague or ambiguous in their requirements, it is crucial for sponsors to ensure that they fully comprehend what compliance entails.  

For example, the 25-year retention period stipulated in the above-mentioned clinical trial regulation realistically requires active digital preservation to guarantee that each file is readable for the entire duration. In our experience, most do not fully comprehend this requirement. 

The future of inspections – remote, in-person or hybrid? 

Over the last couple of years’, inspections have been forced online, moving away from the traditional in-person approach. 

With lockdowns easing across the world (as evidenced by being able to attend an in-person event for the first time in 2 years) questions are now being raised about what the future for regulatory inspections hold.  

Perhaps – unsurprisingly – opinions were mixed about what TMF professionals would prefer going forward. A poll conducted during one of the sessions pointed towards a general consensus that a hybrid approach would be the most likely to be adopted (with no one believing in a return to full in-person inspections).  

Time will tell what the futures holds but I’ll be fascinated to watch where this goes and the impact it will have on inspections and inspection readiness. 

Collaboration between Sponsors, CROs and Sites. 

It was encouraging to see presentation time given to sites in what is traditionally a sponsor dominated event – and it highlighted a key challenge which is not necessarily unique to the clinical trial space.  

Collaboration and communication between different commercial entities working on the same projects requires an open dialogue and mutual understanding of the environment (and related challenges) that they operate in.  

There seemed to be unanimity in the room about the value of a more joined up approach between sponsor and sites. One area that was mentioned was the possible standardisation of approaches and frameworks used by both parties to simplify the working relationship.  

Wrapping up… 

I’ve really only scraped the surface on some of the key themes covered at the event and I have purposefully not even mentioned the news of the TMF Reference Model’s absorption into CDISC (we’ll cover this in a future blog post). 

What I do hope is that I’ve given you a flavour of some of the key themes discussed at the event and highlighted some of the challenges and questions that currently exist with the management of the TMF and broader clinical trial space. 

If you would like to discuss any of the topics I’ve covered in this post, feel free to reach out to me at Tom.Lynam@Arkivum.com 

Tom Lynam

Tom is the Marketing Director at Arkivum. He joined the business in January 2020 tasked with driving new business growth and building the brand into new sectors such as Pharmaceutical and Life Sciences. He has over 12 years’ experience in several diverse marketing leadership roles across technology and professional services organisations.

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