Four Reasons why the FDA’s 2-year Clinical Record Retention Requirement is Obsolete

When sponsors and investigators look at the U.S. Code of Federal Regulations for clinical trials, they often zero in on the FDA’s stated retention requirements: two years for IND and IDE records, and three years for IRB records.

At first glance, these rules might suggest that clinical research documentation has only a short shelf life. But I would argue that in reality, these timelines are functionally obsolete for any modern, global clinical research organisation.

In this blog post I’ll explore why I believe this is the case.

1. Outdated rules in a digital clinical landscape

The FDA’s 2-year requirement, found in 21 CFR 312.62(c) (for drugs) and 21 CFR 812.140(d) (for devices), were first published in 1980’s and have undergone little change since. At the time, trials were smaller, often limited to the U.S., and primarily paper based. Regulators believed that once a product was approved—or a development program abandoned—there was little need to keep records longer.

Fast-forward to today’s environment: clinical research is multinational, highly regulated, and increasingly digital. Studies generate vast amounts of data that underpin not only initial approvals but also label expansions, safety reviews, and long-term scientific understanding. Two years does not reflect the realities of contemporary clinical research.

2. Europe raised the bar

Across the Atlantic, the EU Clinical Trials Regulation (EU CTR), published in 2014 and transitioning into effect throughout the early 2020s, requires sponsors to retain the trial master file (TMF/eTMF) for at least 25 years. This reflects a very different philosophy: one that prioritises long-term subject protection, data transparency, and scientific reproducibility.

The 25-year retention period has also recently been echoed by the MHRA with their updated UK clinical trail regulation coming into effect in early 2026.

For sponsors operating globally, the European standard effectively sets the bar. Destroying records after two years in the U.S. while maintaining them for decades in Europe would create unmanageable compliance risks. Most global companies sensibly choose to follow the stricter requirement everywhere. A highest, lowest common denominator.

3. ICH E6(R3) sets global GCP expectations

The recently updated ICH E6(R3) for Good Clinical Practice guidelines, (and endorsed by both the FDA and EMA), requires sponsors and sites to retain records in line within applicable regulatory requirements.

While a US sponsor may just want look towards the FDA in this instance, given that the EU and UK demand 25 years, the ICH position means U.S. sponsors must default to the longer timeline if they want to align global compliance expectations.

4. Practical legal considerations

Even without EU or ICH requirements, U.S. sponsors face practical pressures that make destroying records after only 2-years a high-risk approach:

• Product liability litigation often requires access to historical trial records decades after approval.
• Post-marketing safety surveillance depends on archived data to investigate potential risks years later.
• Future indications or label expansions may rely on data from earlier studies.

I’d argue no responsible sponsor would risk destroying key documentation after two years given the above. In addition for smaller to medium sized pharma and biotech’s, these records are essential in any future M&A activity.

In Summary

In practice, the FDA’s 2-year requirement is an outdated regulatory floor, not a meaningful standard for sponsors and sites to adhere to. I’d argue the real benchmark for sponsors is at least 25 years, driven by EU (and soon to be UK) law, supported by ICH guidelines and ultimately included within common-sense risk management.

2 years might look permissive on paper, but in practice it’s obsolete. Sponsors who treat it as sufficient are not only out of step with international norms, but also exposing themselves to serious legal, regulatory, and reputational risks.

For U.S. sponsors, the smarter path is clear: align with the strictest global requirement. By treating 25 years as the minimum, companies ensure compliance, improve patient safety, preserve the integrity of their science and protect commercial assets.