Don’t Fear the Archive: TMF Archiving Tips to Rest Easy

Happy Halloween from the team at LMK! 🎃

We’ve been carving pumpkins, stashing away candy (some of which might actually make it to trick-or-treaters), and breaking out our best zombie moves every time “Thriller” starts up on our playlist. Halloween is spooky for many reasons, but here’s a frightening thought: Thriller came out nearly 35 years ago! While that’s an eternity in pop culture, it’s nothing compared to how long your trial master file (TMF) may need to be archived. For those managing clinical trials, maintaining inspection-ready TMFs brings its own set of eerie challenges that can feel like a horror story all on its own.
In clinical research, your TMF isn’t just a dusty relic to be tucked away and forgotten. It’s a vital document that could be summoned back from the “afterlife” even decades after a trial has ended. Regulations are clear that TMFs must be stored for a significant period, but the details can be murky. Toss in electronic TMFs, changing formats, and the mountain of legal, regulatory, and local requirements, and suddenly your TMF can seem like it’s crawling back from the grave, demanding ongoing attention.

So, what’s needed to keep your TMF “resting peacefully” for the long haul? Here’s a breakdown of archiving requirements that could apply to your TMF:
1. FDA 21 CFR 312.57 (c): US sponsors must retain records for two years after a drug’s marketing application is approved, or if the application isn’t approved, for two years after investigational use ends and the FDA is informed.
2. ICH E6 Section 5.5.11: Essential documents should be kept for at least two years following the last approval of a marketing application in any ICH region or until two years after formally discontinuing clinical development.
3. European Directive 2005/28/EC Article 17: Requires sponsors and investigators to retain essential documents for at least five years post-trial, though local requirements or sponsor agreements may extend this time.
4. European Directive 2003/63/EC Annex 1 Chapter 5: Requires documents to be kept for at least 15 years post-trial or for two years following final marketing authorization.
5. Health Canada’s Guidance Document: Canadian regulations specify the longest retention period—25 years for all records referred to in applicable regulations.
These requirements highlight just how crucial it is to archive your TMF. However, archiving can’t be an afterthought; it’s a critical component of your TMF strategy that demands foresight and planning. Implementing a holistic archiving plan at the start of a trial can help prevent some truly terrifying headaches down the road. Here are some elements to consider:

• Compliance: Have you mapped out which specific regulations apply to your TMF? Non-compliance could put the entire trial’s credibility in jeopardy, raising concerns over data quality and patient safety.
• Security: Stories of high-profile data breaches are chilling reminders of the risks involved. An archive that isn’t properly secured could lead to significant legal and regulatory fallout.
• Accessibility: Imagine trying to retrieve documents from an eight-inch floppy disk! Whether it’s digital or paper, your archived TMF should be easily accessible to inspectors and stakeholders, regardless of format or origin.
• Efficiency: Managing the archiving process in a streamlined way prevents it from becoming a drain on time and resources. The last thing you want is for archiving to get bogged down by inefficiencies, leaving it vulnerable to human error.
• Cost: The expenses associated with archiving can pile up over time, especially if you rely on physical storage. Make sure your organization budgets for long-term costs, whether for digital infrastructure, cloud storage, or the personnel needed to maintain it.
In the final stages of a trial, archiving is often the last item on the list, easily overlooked as resources shift to new projects. But without a solid plan, TMF archiving can easily come back to haunt you. Establishing a well-thought-out strategy before the trial begins ensures that everyone understands their roles and responsibilities. That way, when it’s time to put the TMF to rest, all stakeholders are prepared, and all regulatory requirements are met.
While Halloween comes only once a year, an unprepared TMF archive could give you nightmares year-round. So as you close out trials, remember that archiving doesn’t happen in isolation—it’s an essential step to ensure that your TMF is resting in peace andready to meet any future inspection demands, even decades down the line.