UK Extends Clinical Trial Record Retention to 25 Years – Is Your Archive Ready?

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance that fundamentally changes the landscape for clinical trial record retention. Coming into force April 28, 2026, the new regulations require that for clinical trials with applications submitted on or after this date, sponsors and investigators must retain Trial Master Files and participant medical records for at least 25 years from trial conclusion – a five-fold increase from the previous 5-year requirement. For ongoing trials (applications submitted before April 28, 2026), Trial Master Files retain the 5-year requirement, but participant medical records must follow the new 25-year retention period. If, at the end of the 25-year retention period, the trial data is being used to support a pending UK marketing authorization application, records must be retained for an additional 2 years after that UK MA is granted.

This extended timeline presents significant challenges for sponsors:

• Where will these records be stored for a quarter century?

• Who maintains responsibility if your organization restructures or a CRO partnership ends?

The new guidance addresses this directly, requiring sponsors to appoint a named individual responsible for archiving and mandating that records remain “readily available, complete, and legible” throughout the entire retention period. If a sponsor closes or enters administration, the responsibility transfers to the Chief Investigator – but the regulatory obligation remains.