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D
Data protection officer (DPO)
D
Data quality
D
Data retention
D
Data subject
D
Data transfer
E
Early termination of a clinical trial
E
Electronic Clinical Outcome Assessment (eCOA)
E
Electronic case report form (eCRF)
E
Electronic data capture (EDC)
E
Electronic health record (EHR)
E
End of a clinical trial
E
Enterprise
E
Ethics committee
E
European Data Protection Board (EDPB)
E
European Data Protection Supervisor (EDPS)
E
European Medicines Agency (EMA)
F
Fairness and Transparency
Filing system
F
First-in-class drugs
F
Food and Drug Administration (FDA)
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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

T

Third country

A third country, in the sense of the GDPR, is a country which is not bound by the GDPR - as opposed to the 28 Member States of the EU and the three European Economic Area (EEA) countries Norway, Liechtenstein and Iceland.

Third countries may be recognised through an adequacy decision as offering an adequate level of protection for personal data in order to enable transfers of personal data from the EU and EEA Member States to them.

The effect of such a decision is that personal data can flow from the EU and EEA Member States to that third country (within the limit of the material scope as described by each Decision) without any further requirements.

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