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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.

I

Informed consent

Informed consent is a subject's free and voluntary expression of their willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that are relevant to the decision to participate (Art. 2(2)(21) EU Clinical Trials Regulation 536/2014). It must be written, dated and signed by the person conducting the interview and by the subject or their legally designated representative, after an interview in which the subject has been able to ask questions and has had adequate time to consider (Art. 29 CTR; ICH E6 GCP section 4.8).

The information provided must cover the nature, objectives, benefits, implications, risks and inconveniences of the trial, the subject's rights including the right to withdraw without detriment, the conditions of the trial, alternative treatments, compensation and insurance, the EU trial number and the availability of results. National law adds requirements, and ethics committees review the informed consent form (ICF) as part of the Part II assessment. Electronic consent (eConsent) is permitted subject to national rules.

Informed consent to participate is not the same as consent as a legal basis under the GDPR. The EDPB (Opinion 3/2019) confirms that the legal basis for processing trial data is usually a legal obligation, public interest or legitimate interest combined with Art. 9(2)(i) or (j), and that the ICF must therefore contain the Art. 13 GDPR information (controller identity, purposes, legal basis, recipients, transfers, retention, rights) as a transparency measure rather than as a consent request. Getting this distinction wrong leads to invalid consent clauses and to unworkable withdrawal promises. iliomad reviews ICFs against a jurisdiction-specific GDPR checklist; see ICF review services and the mandatory GDPR information for ICFs resource.

Is a participant's informed consent to the trial the same as consent under the GDPR?

No. Informed consent under Art. 28 and 29 of the Clinical Trials Regulation is an ethical and procedural requirement to take part in the study. Consent under the GDPR is only one possible legal basis for processing personal data, and the EDPB considers that it will often not be the most appropriate basis for core trial processing, notably where there is an imbalance between sponsor and participant or where withdrawal would make data unusable. Many sponsors therefore rely on public interest or legitimate interests as the GDPR basis, while still obtaining informed consent to participate. The ICF must explain both clearly, so that participants understand what they agree to and how their data is used.