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R
Randomised clinical trial (RCT)
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Real-world data (RWD)
R
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R
Regulatory intelligence
R
Re-identification risk (motivated intruder test)
R
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R
Right not to be subject to solely automated decision-making
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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Secondary use of health data
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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
Trial master file (TMF)
T
Trusted research environment (TRE)
U
UK GDPR
U
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U
US CLOUD Act
V
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V
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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.

D

Data monitoring committee (DMC)

A data monitoring committee (DMC), also called a data and safety monitoring board (DSMB) or independent data monitoring committee (IDMC), is a group of independent experts, typically clinicians and a statistician, appointed by the sponsor to review accumulating safety and, where relevant, efficacy data from an ongoing clinical trial and to recommend whether the trial should continue unchanged, be modified or be stopped. Its operation is described in a DMC charter, in line with the EMA guideline on data monitoring committees (2005) and FDA guidance (2006), and it is referenced in ICH E6 and E9.

DMCs are expected in trials with mortality or major morbidity endpoints, in vulnerable populations, in long-duration or adaptive trials, and wherever interim analyses may lead to early stopping for benefit, harm or futility. The DMC sees unblinded data prepared by an independent statistician, while the sponsor and investigators remain blinded.

The unblinded interim datasets are pseudonymised health data and are among the most sensitive information generated in a trial, both for participants and for the sponsor's commercial position. Access controls, confidentiality agreements, secure transfer to committee members (who may be located outside the EEA) and clear allocation of controller and processor roles for the independent statistical centre should be addressed in the charter and in the trial's DPIA.

Does a data monitoring committee replace the sponsor’s decision-making responsibility?

No. A DMC generally provides independent recommendations about whether a trial should continue, change or stop; the sponsor remains responsible for deciding and acting within the applicable requirements. Define how recommendations are communicated and escalated in the committee charter, while protecting confidential interim results and the trial blind.