A Trial Master File (TMF) is a collection of documents that helps ensure a clinical trial is conducted according to regulatory guidelines. But when your TMF is a mess, it can leave you wanting to turn back time.
The scene may be familiar: You’ve spent months or even years of demanding work running your life-impacting trial. Now the inspectors have arrived – and they want to see your TMF.
The good news? You have a TMF. The bad news? Everyone is sure that someone was managing it. Maybe the CRO. Maybe the Clinical team has it on a shared drive. It’s at moments like this when you can go from excitement to wishing you had a time machine to go back and “fix” your TMF.
If you do figure out how to time travel, please get in touch with us directly to share. In the meantime, here are three quick tips for active TMF management you can work on today:
1. Make the TMF Tangible
Even though a TMF is a regulatory requirement, that doesn’t mean your study team members know what it is – let alone where it is – or what they are supposed to do with it. Having a quality TMF can be invaluable since it can allow the team to review and reference trial documents quickly and easily. It can also prevent the loss of important documents and ensures the quality of the data collected throughout the trial.
Therefore, it’s vital your team knows these points:
- Why the TMF is important: The TMF is the story of your clinical trial, it is the proof that you conducted the trial in accordance with regulation.
- Where the TMF is: Do you have an eTMF, or is it hosted by a CRO partner?
- How to access your TMF: Wherever your TMF is, provide concise instructions on how to access it, don’t make the team search for it!
- What your team needs to do with the TMF: The team should maintain the TMF so that it’s up-to-date. This makes it easier when inspections come around.
- You are all the co-authors of the TMF: Since the TMF is the story of your clinical trial, the study team is all the co-authors. It is the team’s responsibility to make sure the story is complete!
2. Provide Simple Tools
Your teams may only interact with the TMF occasionally, and for some team members, that’s a reasonable reality. However, those team members may struggle to remember how to perform certain tasks related to the TMF, and they likely won’t know all the latest updates and procedures for using it. So giving your team simple tools like review templates or a reference card that summarizes expectations and how to perform key tasks can go a long way to ensuring everyone stays on the same page.
3. Oversee and Support
While it would be nice, a TMF won’t magically create itself. So, whether you are a small team using your CRO’s TMF or a large organization with a full TMF Operations team, you must oversee TMF management to ensure compliance.
Even though this may seem scary at first, the truth is this doesn’t have to be complex. For example, you can provide documented updates at shared forums like team meetings, where you can reshare your tools and task expectations. This is a fantastic way to start incorporating TMF into trial delivery. Make sure you file the update in your TMF and do it consistently to document your oversight.
Have an electronic trial master file (eTMF)? Consider sending the update as a review task to the study team. That way, the updates live in the TMF from creation. Don’t have someone on your team to do this? Ensure you appropriately contract your CRO or a TMF Management provider to do this on your behalf.
Supporting this key trial activity is crucial, so don’t consider it only at inspection time. Your TMF won’t instantly be perfect, but demonstrating consistent oversight and supporting your team shows your commitment to TMF management.
Actively managing your TMF is a constant pursuit that will need to evolve over time. Start simple, be clear about expectations, provide support and stay consistent. The TMF will become a natural part of trial delivery, and you won’t be stuck wishing for that time machine.