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21 CFR Part 11
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510(k) premarket notification
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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

European Data Protection Supervisor (EDPS)

The European Data Protection Supervisor (EDPS) is the independent supervisory authority responsible for ensuring that the EU institutions, bodies, offices and agencies respect data protection law when processing personal data. Its legal framework is Regulation (EU) 2018/1725, the equivalent of the GDPR for the EU administration, which mirrors the GDPR's principles and data subject rights with some adaptations.

The EDPS supervises bodies such as the European Commission, the European Medicines Agency and the European Centre for Disease Prevention and Control, and therefore oversees systems like CTIS, EudraVigilance and the EMA's clinical data publication policy. It advises the EU legislator on proposals with data protection impact, having issued opinions on the AI Act, the European Health Data Space, the Data Act and the pharmaceutical package. The EDPS is also a member of the EDPB and provides its secretariat.

Sponsors and CROs do not fall under EDPS supervision directly, since they are regulated by national authorities. They encounter the EDPS indirectly: when EMA processes their submissions, when personal data of investigators is published on the CTIS public portal, and when EDPS positions (for example on scientific research or on anonymisation of clinical reports) influence EDPB and national practice. The EDPS and the EDPB together also form the European Data Protection Seal referential.

Does the EDPS supervise every private clinical-trial sponsor?

No. The EDPS supervises personal-data processing by EU institutions, bodies, offices and agencies. Private sponsors generally deal with the competent national data-protection authorities under the GDPR. EDPS guidance may still be informative, particularly when a sponsor interacts with an EU agency, but its institutional remit should not be confused with direct supervision of the sponsor.