Key Takeaways from The “Quality Checks in GxP Archiving” Webinar

Archiving often feels like the final administrative task in a long clinical study, the moment the team can finally exhale and move on. But as I explained in my recent webinar with Arkivum, this last step carries far more significance than many organisations consider. The quality of your archived Trial Master File (TMF) can have an impact on future inspections, regulatory submissions, licensing decisions and, ultimately, trust in your organisation’s work. When a TMF may be examined decades after the study closes, “good enough” simply isn’t good enough. 

The Long Shadow of Poor Archiving 

Most TMFs are archived for 25 years or more. They may never be revisited, but if they are, the expectations placed on them will be just as high as the day they were created. Missing documents, poor metadata, misplaced files, or incomplete storylines can undermine the credibility of an entire study. While regulatory standards and inspection practices evolve over time, authorities understand that documentation reflects the standards of its era as long as the TMF was placed into storage in a quality-controlled state. A well QC’d TMF is defensible; an unreviewed one is a risk waiting to surface. 

Why Functional Teams Must Own Their QC 

In small organisations, it’s common for a single Clinical Trial Assistant (CTA) or TMF Lead to handle QC for the whole file. But as studies grow more complex and study teams grow, this approach becomes difficult to sustain. I encourage teams to move towards functional ownership, where each group reviews the records they created or oversaw. 

This works because functions understand the context of their documentation, what should exist, why it matters and whether anything is missing. To support this, include two extra columns in the TMF index (I recommend use of the CDISC TMF Index): one identifying the responsible function for each record type, and one showing where that document is located. These simple additions reduce confusion, prevent ownership disputes and ensure that documents stored outside the eTMF aren’t overlooked. 

A Risk-Based Approach to QC 

Not every study needs the same level of scrutiny. A risk-based approach allows organisations to focus their QC efforts where they matter most. This means considering the asset’s lifecycle, study design, and how likely the TMF is to be revisited. Tools developed by CDISC, including the TMF Risk Management White Paper and the TMF Risk-Based Tool help teams identify the areas most critical to review. ICH E8(R1), section 3.2 and 3.3 encourages teams to identify “critical-to-quality” factors so QC efforts align with what most influences study integrity. 

Timing is Everything 

Quality checks should take place before archiving. Doing so ensures the project team, especially clinical operations, who are responsible for the majority of TMF content are still available to resolve gaps or errors. It also avoids unlocking archives later, which can introduce confusion during audits and complicate the chain of custody. I encourage teams to align QC timing with the final filing milestone, ensuring everything is reviewed while study knowledge is still fresh. 

Making QC Practical 

There is a lot of value using eTMF QC functionality rather than working outside the system. While initially perceived as time-consuming, these tools provide audit trails, consistency, and traceability that become invaluable over time. QC should assess completeness, document quality, metadata accuracy, and unwanted duplicates. Evidence of the review should be captured through a simple QC certificate, which reassures inspectors without cluttering the TMF with internal notes. 

A Final Reminder 

Pulling a TMF from the archive years later only to discover avoidable gaps is not just inconvenient, it can be extremely costly, difficult and, in some cases, impossible to fix. Quality checks may feel like the final hurdle in a long study, but they are also your last opportunity to ensure the TMF can stand up to future scrutiny. 

Access the video recording of the webinar Quality Checks in GxP Archiving: The Hidden Steps You Can’t Afford to Miss 

Sarah Hitching from Hedian Records Management