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21 CFR Part 11
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

E

End of a clinical trial

The end of a clinical trial means the last visit of the last subject, or a later point in time defined in the protocol (Art. 2(2)(26) EU Clinical Trials Regulation 536/2014). The definition is important because several regulatory clocks start on that date.

Under Art. 37 CTR the sponsor must notify the end of the trial in each Member State concerned, and the global end of the trial, through CTIS within 15 days, and must submit a summary of results and a lay-person summary within one year (six months for paediatric trials), regardless of outcome. Under Art. 58 the 25-year archiving period for the clinical trial master file runs from the end of the trial. Compare early termination and temporary halt.

Operationally, the end of a trial triggers database lock, pseudonymised data transfer to the sponsor's archive, decommissioning of vendor platforms, return or destruction of data held by processors, and the point from which the storage limitation analysis for each data category should be documented. Participants' information should already have explained what happens to their data at this stage, including any planned secondary use or anonymisation for data sharing.

Does database lock determine the legal end date of an EU clinical trial?

Not by itself. Under the CTR, the end is the last participant’s last visit or a later point specified in the protocol. Database lock is a separate data-management milestone. Keep these dates distinct in the close-out plan, since regulatory notifications and record-retention calculations depend on the applicable trial-end definition.