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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.

S

Storage limitation (limited storage periods)

Storage limitation, often described as the principle of limited storage periods, is set out in Art. 5(1)(e) GDPR: personal data must be kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed. Data may be stored for longer periods insofar as it will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, subject to the implementation of the appropriate safeguards required by Art. 89(1).

The principle does not prescribe fixed periods. It requires the controller to define a period, or the criteria used to determine it, for each purpose, to communicate it in the information notice (Art. 13(2)(a)), and to delete or anonymise the data when it expires. "Necessary" is assessed against the purpose and against other legal obligations: the 25-year archiving of the clinical trial master file under Art. 58 CTR, product liability periods, pharmacovigilance retention and tax law all legitimately extend storage.

In practice the principle is implemented through a retention schedule, technical deletion or archiving routines, and periodic reviews, and it is one of the most common findings in supervisory authority investigations because organisations rarely delete anything. Pseudonymised research data kept indefinitely "for future research" must be justified under Art. 89 safeguards and disclosed as such; otherwise it breaches the principle.

Does storage limitation require immediate deletion when a trial ends?

No. The end of active data collection is not necessarily the end of every justified retention purpose. Assess applicable archiving duties and other documented needs by record category. Storage limitation requires a defensible duration, controlled access and disposal when retention is no longer justified, rather than automatic deletion or indefinite storage.