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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.

D

Data Protection Representative (DPR)

A Data Protection Representative (DPR) is the natural or legal person established in the EU, designated in writing by a controller or processor not established in the EU, to represent it with regard to its GDPR obligations (Art. 4(17) and Art. 27). The obligation arises whenever a non-EU organisation falls within the extraterritorial scope of Art. 3(2), that is, when it offers goods or services to, or monitors the behaviour of, individuals in the EU, which is the case for any non-EU sponsor recruiting EU trial participants or any HealthTech company with EU users.

The representative must be established in one of the Member States where the data subjects are located, is mandated to be addressed by supervisory authorities and data subjects on all issues related to processing, and maintains the record of processing activities on behalf of the controller (Art. 30). The exemption in Art. 27(2) for occasional, low-risk processing does not apply where special category data such as health data is processed on a large scale. The EDPB Guidelines 3/2018 clarify that the representative is not itself liable for the controller's breaches but can be the addressee of enforcement measures.

Parallel obligations exist under Art. 3A of the UK GDPR for organisations outside the UK, and under Art. 14 of the Swiss revFADP for organisations outside Switzerland. A US biotech running a European trial therefore typically needs an EU, a UK and a Swiss representative. iliomad acts as EU Data Protection Representative, UK representative and Swiss representative for life sciences companies.

Does appointing an EU representative transfer the sponsor’s GDPR responsibilities?

No. An Article 27 representative provides an EU contact point for individuals and supervisory authorities; the appointment does not remove the controller’s or processor’s own responsibilities. A non-EU sponsor should document the mandate and communication routes while retaining ownership of its compliance decisions, security arrangements and responses to data protection issues.