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Randomised clinical trial (RCT)
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Regulatory intelligence
R
Re-identification risk (motivated intruder test)
R
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R
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R
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R
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R
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R
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Schrems II
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Scientific research purposes (Art. 89 GDPR)
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Shadow AI
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SNDS (Système National des Données de Santé)
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Start of a clinical trial
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Swiss Federal Act on Data Protection (FADP / revFADP)
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Swissmedic
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Synthetic data
T
Technical and organisational measures (TOMs)
T
Temporary halt of a clinical trial
T
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T
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U
UK GDPR
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U
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V
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V
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W
Wearables and digital health technologies (DHT)
W
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W
World Health Organization (WHO)
X
XAI (explainable artificial intelligence)
Y
Yellow Card scheme (UK)
Z
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.

I

Interactive web response system (IWRS)

An interactive web response system (IWRS) is a web-based application used in clinical trials to randomise subjects, assign and track investigational product kits, manage site and depot inventory, and perform controlled unblinding. It is the internet-based successor to the interactive voice response system (IVRS), which performed the same functions by telephone keypad, and both are now grouped under the umbrella terms interactive response technology (IRT) and randomisation and trial supply management (RTSM).

Site staff log in to the IWRS at screening, randomisation and each dispensing visit; the system returns a kit number that preserves the blind and updates inventory in real time, prompting the sponsor's supply chain to resupply. Emergency unblinding is available to the investigator with full audit logging, and integration with the EDC system avoids duplicate data entry.

Data protection considerations mirror those of any IRT system: the vendor is a processor under an Art. 28 GDPR agreement, data is pseudonymised and limited to randomisation-relevant variables, hosting location determines transfer requirements, and user accounts of site personnel constitute personal data requiring their own information notice. Validation documentation and access logs are routinely requested during GCP inspections.

Is an IWRS the same thing as the trial’s EDC system?

No. An IWRS typically supports workflows such as randomisation and investigational-product allocation, while EDC manages study data capture and queries. The systems can exchange information but serve different purposes. Define which system owns each data item and test interfaces so that discrepancies do not compromise allocation, dispensing or blinding.