Click here to open the filter panel
U
UK GDPR
U
Unexpected serious adverse reaction (SUSAR)
V
Validation (computerised system validation, CSV)
V
Vendor assessment (third-party risk management)
V
Vital interests (Art. 6(1)(d) GDPR)
V
Vulnerable participants (vulnerable subjects)
W
Wearables and digital health technologies (DHT)
W
Withdrawal (of consent and from a clinical trial)
W
World Health Organization (WHO)
X
XAI (explainable artificial intelligence)
Y
Yellow Card scheme (UK)
Z
Zero-knowledge proof
Z
Zero trust architecture
Click a letter to view all its definitions
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

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

Standard contractual clauses (SCC)

Standard contractual clauses (SCCs) are model data protection clauses adopted by the European Commission under Art. 46(2)(c) GDPR which, when incorporated without modification into a contract between a data exporter subject to the GDPR and a data importer in a third country, provide appropriate safeguards for the international transfer of personal data. The current set, adopted by Implementing Decision (EU) 2021/914, replaced the 2001, 2004 and 2010 clauses, which could no longer be used after 27 December 2022.

The 2021 SCCs use a modular structure: Module 1 controller to controller, Module 2 controller to processor, Module 3 processor to processor, and Module 4 processor to controller. The parties select the module, complete Annex I (parties and description of the transfer), Annex II (technical and organisational measures) and Annex III (sub-processors), and may add a docking clause, an optional redress clause and the choice of governing law and forum within the EU. Modules 2 and 3 also satisfy the Art. 28 requirements, so a separate DPA is not strictly needed for the transfer relationship. Clause 14 obliges the parties to carry out and document a transfer impact assessment of the importer's local laws, and Clause 15 governs responses to government access requests, both codifying the Schrems II requirements; where the assessment reveals a risk, supplementary measures are needed.

The SCCs cannot be used where the importer is itself directly subject to the GDPR under Art. 3(2); the Commission has announced a dedicated set of clauses for that case. The UK uses its own International Data Transfer Agreement or the UK Addendum to the EU SCCs, and Switzerland requires specific adaptations of the EU SCCs recognised by the FDPIC. In clinical research, SCCs are concluded between EU sponsors or sites and non-EU sponsors, CROs, central laboratories and technology vendors; they do not cover disclosures to non-EU regulators such as the FDA, which rely on Art. 49(1)(d). iliomad reviews and completes SCCs as part of its contractual review services.