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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.

P

Processor

A processor is a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller (Art. 4(8) GDPR). The processor acts only on the controller's documented instructions and does not determine the purposes of processing or its essential means; if it does, it becomes a controller (or joint controller) for that processing, as the EDPB Guidelines 07/2020 explain.

Art. 28 requires a binding contract or other legal act setting out the subject matter, duration, nature and purpose of processing, the types of data and categories of data subjects, and the obligations of the processor: process only on instructions, ensure confidentiality of staff, implement Art. 32 security measures, engage sub-processors only with authorisation and under the same terms, assist the controller with data subject rights, DPIAs and breach notification, delete or return data at the end of the contract, and make available information for audits. Processors have direct statutory duties too: maintaining a record (Art. 30(2)), appointing a DPO and an EU representative where required, notifying breaches to the controller, and complying with Chapter V on transfers.

In clinical research the typical processors are the CRO, EDC, eCOA and IRT vendors, central laboratories, imaging core labs, safety database providers, translation agencies and cloud hosts. Investigator sites, by contrast, are usually controllers. Assigning the wrong role in a contract does not change the legal reality but does create liability confusion, which is why role mapping is an early step in every DPIA and vendor assessment.