Well, first and foremost, welcome!
Rob Jones has relinquished control and I’ve been given free rein to bring you the last blog in the series on TMF Management in Clinical Trials. Those with an interest in British history will know that a Yorkshireman does not hand over power to an (honorary) Lancastrian easily, so the pressure is on! However, if you’re dipping into this blog without having read Rob’s Simple TMF Processes and The Path to Metric Nirvana, I highly recommend you take a moment to revisit these too. Alongside today’s blog, these cover the TMF Management trifecta of People, Process and Technology.
Process and Technology sussed – what next?
To get here you’ve already invested some significant time and money. You’ve won the business case for implementing an eTMF and selected the system that’s right for you. You’ve started writing your new SOPs and processes, with what feels like countless revisions and edits in the vain attempt to get V1.0 finalized before the eTMF goes live (spoiler alert – you’ll be writing V1.1 within a week)! You’re busy defining the metrics and discussing thresholds, ready to keep a close eye on your TMF Health. All the foundations are now in place to be eTMF superstars, right?
Not so quick… there’s one more piece to the puzzle to consider.
With a greater TMF comes great responsibility
TMF Management has come a long way in 20 years. Lever arch files have morphed into the cloud, cardboard dividers have transformed into tree-view, and plastic wallets have converted placeholders. Critically, the feeling of rising panic as the lever arch file gets so full that you might have to introduce an ‘a’ and ‘b’ and mess up your perfect sequential numbering system is long gone! Now it’s all talk of completeness questions, placeholders, EDLs, workflows, milestones, quality reviews, and a whole host of new terminology and acronyms that at first glance can baffle the smartest of minds.
Whether you’re moving to an eTMF for the first time, or taking back control and bringing the eTMF in-house, there is a trade-off to be made. By taking the positive step in using technology to your advantage, to become more compliant and inspection ready, you are accepting the huge shift from passive to active TMF management. In doing so, you are also accepting that a greater investment needs to be made in resource and time.
The people. The last piece of the trifecta.
Once upon a time there was speculation that the introduction of intelligent and efficient eTMF technology would lead to a decrease in the amount of human input required. In reality the opposite is true, and an even greater collaborative effort is required: from IT to implement the system, QA to ensure it meets standards, TMF Operations to manage system oversight, and of course the Study Team who generate the documents.
However, for those of you with eagle-eyes you’ll notice we’ve still got a gap. We’ve got system oversight, we’ve got study documents, but what about the management of the study in the system? How do we know what documents should be there? How do we know what shouldn’t be there? Who is creating placeholders or updating the EDLs? How do we know what’s there is accurate? How do the study team know when to complete a quality review? Who answers the TMF questions? So many questions – have you got the answer?
Failing to prepare is preparing to fail!
When it comes to getting a drug to market the TMF suddenly becomes the focus of everyone's attention. The buzzwords 'inspection ready' are ones we’re all too familiar with. At any time, you could be given notice of a Regulatory Authority visit and you need to be ready for battle. To do this effectively and help reduce the last-minute panic, you must prepare from the get-go. In short, you need people in place to be managing the study TMFs from day one.
It is tempting to suggest that the study-level TMF activities could be absorbed between TMF Operations and the study team. However, does a jack of all trades achieve the highest levels of quality? Would you expect data management to deliver guidance on clinical supplies? Would you want your study manager to be responsible for writing the CSR? They may know the basic principles, but each has its own regulations, and the eTMF is certainly no different. Even TMF Operations would struggle – they are responsible for oversight of the whole department and to focus on individual studies requires a different strategy altogether. No, to achieve the best results you need a master, a master of the study-level TMF.
eTMF: the rise of the Study Owner
The last 10 years have seen a rise in the role of the TMF Study Owner. With alias’ such as TMF Leads, TMF Managers or Snr TMF Specialists (to name a few), they are the TMF gatekeepers, the subject matter experts; they are your secret weapon in the mission to achieve eTMF magnificence. Study Owners are experts in their field with specialist knowledge of TMF best practices and regulations, combined with the ability to infiltrate and collaborate with the front-line study team.
So, by this point you’re probably wondering, how does this unicorn really help? What do they do that we’re not already doing? Why do we need to invest even MORE money into our eTMF management?
Look no further, here are our top 5 ways Study Owners can help you run the trial in your eTMF:
- Promote positive TMF culture within your organization
We cannot expect every member of the study team to secretly be a TMF geek who strives for documentation perfection. However, what we can do is promote a positive TMF culture. This means increasing the understanding of why TMF is important, but also ensuring the processes put in place make it as easy as possible to be compliant. Positioning Study Owners as part of the study team ensures the TMF function is always represented and visible, while also facilitating and enabling the study team in TMF activities.
- Give each study the best foundations for TMF success
Just as every trial starts with a Protocol, every TMF should start with a Management Plan. The Study Owner plays a critical part in ensuring the requirements of the study and the TMF are in alignment and documented, knowing the questions to ask and the information to gather. They can take responsibility for oversight in ensuring expectations are being met, with no other single person across the study team in a position to do this as effectively.
- Be the master builders in your study eTMF construction
Set-up and maintenance of the eTMF is a complex beast, with each eTMF system having its own unique features. To use them to your full advantage at a study level, you need an expert who is prepared to explore, learn, and understand the inner workings. A Study Owner combines this system knowledge with study information gathered from the wider study team, to build you a fit-for-purpose TMF, tailored to your study, that can be modified at the drop of a hat when things change, and events occur. They can guide you round the build, telling you what’s there, what’s missing, where the risk factors are; perhaps as importantly, it gives the study team the agency to start guiding themselves too.
- Provide ongoing, consistent, and reliable TMF healthcare
We all know how important it is to have access to healthcare the moment it is needed. Delays do not help anyone. While each function is responsible for looking after their own TMF health, they may not identify underlying issues before it’s too late and the inspector is knocking at the door! The Study Owner is both your GP and critical care for all functions – monitoring the TMF throughout and treating risks ahead of time, but also on hand to respond to emergency incidents that require immediate attention and remediation.
- They can play good cop and bad cop!
Little do the study teams know that behind every Study Owner there is a hive mind of information, waiting to be imparted when the right question is asked – they are the responsive, informative, good cop - helping to keep everyone on track, out of TMF trouble, and with time to focus on their key responsibilities. In return, they also play bad cop and ensure that each function takes accountability for their TMF offences – whether it be late or missing documents, or that overdue quality review. However, whichever part they are playing it is always for the greater good.
I could continue and provide many more ways that Study Owners provide invaluable support for managing studies in the eTMF – we see it first hand on a daily basis here in Professional Services and I also talk from my own personal experience. By investing in Study Owners from the outset, you are helping set yourselves up for eTMF success. Convinced now?
Phlexglobal have been providing Study Owners for over 7 years, with an ever-expanding customer base and increasing reliance on the expertise they provide. We pride ourselves in being system-agnostic, able to support customers in whichever eTMF system implement in their organization. If reading this blog above has made you curious about how Study Owners could help your organization, please get in touch as we’d love to chat with you!
So, there we go… we’ve almost reached the end of the trilogy in 5 parts. We hope you’ve enjoyed joining us on our guide to the eTMF galaxy as much as we’ve enjoyed bringing it to you. For the last part, we’d love it if you would join Rob, I, and our special guest Jenny Fisher, for an Ask the Expert live session on 8th March 2023.
If you missed the Clinical Trials Series Launch you can now watch it on demand here. And don't forget to sign up for series close Ask An Expert session - you can register here.