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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.

B

Binding corporate rules (BCR)

Binding corporate rules (BCR) means personal data protection policies which are adhered to by a controller or processor established on the territory of a Member State for transfers or a set of transfers of personal data to a controller or processor in one or more third countries within a group of undertakings, or group of enterprises engaged in a joint economic activity.