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Randomised clinical trial (RCT)
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Regulatory intelligence
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Re-identification risk (motivated intruder test)
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Schrems II
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Swiss Federal Act on Data Protection (FADP / revFADP)
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Swissmedic
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T
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W
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W
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World Health Organization (WHO)
X
XAI (explainable artificial intelligence)
Y
Yellow Card scheme (UK)
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Zero-knowledge proof
Z
Zero trust architecture
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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.

S

Start of a clinical trial

The start of a clinical trial means the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol (Art. 2(2)(25) EU Clinical Trials Regulation 536/2014). Recruitment activities such as advertising, pre-screening of medical records or approaching patients therefore mark the start, which may precede the first informed consent or first dose by weeks.

Under Art. 36 CTR the sponsor must notify each Member State concerned, through CTIS, of the start of the trial in that Member State within 15 days, and separately of the first visit of the first subject. The trial may only start after the authorisation decision (which under Art. 8 requires both the Part I and Part II assessments, including the ethics committee opinion) and, where applicable, after any GMO authorisation. Recruitment materials themselves form part of the Part II dossier.

Because recruitment already involves processing of personal data (pre-screening logs, referral lists, responses to advertisements, EHR searches for eligible patients), the data protection framework must be complete before the start date, not before the first dose: the DPIA finalised, the controller and processor roles allocated in the clinical trial agreement and DPAs, the Art. 27 representative appointed, transfer safeguards signed, and recruitment notices compliant with Art. 13 and 14 GDPR. Pre-screening using medical records without patient contact is a frequent grey area and typically requires a specific basis under national research law.

Is the first dose always the start of an EU clinical trial?

No. Unless the protocol defines it differently, the CTR uses the first act of recruitment. That may occur before dosing or even the first participant visit. Identify the relevant milestone in the recruitment strategy and ensure the sponsor’s notification process uses the correct event for each Member State concerned.