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21 CFR Part 11
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510(k) premarket notification
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Accountability
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Accuracy
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Adequacy decision
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AI literacy (Art. 4 EU AI Act)
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AI Officer
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ALCOA+
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Analysis Data Model (ADaM)
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APPI (Japan's Act on the Protection of Personal Information)
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Article 29 Working Party (WP29)
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Auxiliary medicinal product
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Best-in-class drugs
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Binding corporate rules (BCR)
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Biobank
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Biometric data
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Biotechnology
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Blinding and unblinding
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Breakthrough therapy designation
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Broad consent
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Business associate agreement (BAA)
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CDASH (Clinical Data Acquisition Standards Harmonization)
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CDISC
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Central imaging
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Central laboratory
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Chemistry, Manufacturing and Controls (CMC)
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Clinical outcome assessment (COA)
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Clinical research
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Clinical study
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Clinical study report (CSR)
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Clinical trial agreement (CTA)
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Clinical trial phases
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ClinicalTrials.gov
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Clinical Trials Information System (CTIS)
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Clinical trial site
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Clinical Trials Regulation (CTR) 536/2014
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Clinician-reported outcome (ClinRO)
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CNIL (Commission nationale de l'informatique et des libertés)
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Codes of conduct
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Common Rule (45 CFR 46)
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Common Technical Document (CTD)
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Companion diagnostic
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Conformity assessment (MDR & AI Act)
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Consent
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Contract research organisation (CRO)
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Controller
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Cookies
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Covered entity (HIPAA)
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CPRD (Clinical Practice Research Datalink)
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Cross-border processing
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Data Act
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Database lock
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Data concerning health
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Data Governance Act (DGA)
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Data management plan (DMP)
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Data minimisation
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Data monitoring committee (DMC)
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Data processing agreement (DPA)
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Data protection authority (DPA)
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Data protection by default
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Data protection by design
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Data Protection Impact Assessment (DPIA)
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Data Protection Officer (DPO)
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Data Protection Representative (DPR)
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Data quality
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Data retention
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Data subject
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Data subject access request (DSAR)
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Decentralised clinical trial (DCT)
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Define-XML
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De-identification (HIPAA)
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Differential privacy
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Early termination of a clinical trial
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Electronic case report form (eCRF)
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Electronic clinical outcome assessment (eCOA)
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Electronic data capture (EDC)
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Electronic health record (EHR)
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Electronic informed consent (eConsent)
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EMA Policy 0070
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Encryption
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End of a clinical trial
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Enterprise
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ePRO (electronic patient-reported outcome)
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Ethics committee
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EU AI Office
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EU Artificial Intelligence Act (AI Act)
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EUDAMED
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European Data Protection Board (EDPB)
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European Data Protection Supervisor (EDPS)
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European Health Data Space (EHDS)
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European Medicines Agency (EMA)
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EU-US Data Privacy Framework (DPF)
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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.

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Adequacy decision

An adequacy decision is a decision adopted by the European Commission under Art. 45 GDPR recognising that a third country, a territory, a sector or an international organisation ensures a level of protection for personal data essentially equivalent to that of the EU. Transfers to an adequate destination can take place without any further authorisation or appropriate safeguards.

Countries and frameworks currently covered include Andorra, Argentina, Canada (commercial organisations under PIPEDA), the Faroe Islands, Guernsey, Israel, the Isle of Man, Japan, Jersey, New Zealand, the Republic of Korea, Switzerland, the United Kingdom, Uruguay, Brazil and the United States for organisations certified under the EU-US Data Privacy Framework. Adequacy decisions are reviewed periodically and can be invalidated by the Court of Justice, as happened with Safe Harbour (2015) and Privacy Shield (2020).

For sponsors and CROs, adequacy determines whether a transfer impact assessment and standard contractual clauses are needed for each data flow. A US CRO that is not DPF-certified, for example, still requires SCCs. Adequacy also matters in the other direction: the UK and Switzerland maintain their own lists of adequate destinations.

Does an adequacy decision remove every GDPR duty for a transfer?

No. An applicable adequacy decision addresses the international-transfer route; it does not remove obligations such as a lawful basis, minimisation, transparency or processor arrangements. Check that the decision covers the recipient and transfer concerned, then document the remaining controls just as carefully as for processing within the EEA.