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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.

R

Restriction of processing

Restriction of processing means the marking of stored personal data with the aim of limiting their processing in the future (Art. 4(3) GDPR). Restricted data may still be stored, but any other processing requires the data subject's consent or must be for the establishment, exercise or defence of legal claims, the protection of the rights of another person, or reasons of important public interest (Art. 18(2)).

Restriction is the mechanism through which the right to restriction under Art. 18 is implemented. It applies where the accuracy of data is contested pending verification, where processing is unlawful but the data subject prefers restriction to erasure, where the controller no longer needs the data but the data subject needs it for legal claims, and where an objection is pending. Recital 67 describes possible methods: temporarily moving the data to another system, making it unavailable to users, or temporarily removing it from a website; in automated filing systems restriction should be ensured by technical means and clearly indicated in the system. The controller must inform the data subject before lifting a restriction and must notify recipients of the restriction under Art. 19.

In clinical research, restriction is a more workable response than erasure when a participant withdraws or contests data: the sponsor can flag the record so that it is excluded from further analyses while retaining it to comply with GCP integrity and Art. 58 CTR archiving obligations. EDC and safety systems should therefore support a restriction flag and an audit trail of its application.

Does restricting processing require deletion of the trial record?

No. Restriction normally allows the record to be stored while limiting other uses under Article 18 GDPR. Where a restriction applies, mark the affected data and implement controls that prevent unauthorised use. Document permitted exceptions and the procedure for reviewing or lifting the restriction rather than simply deleting the record.