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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.

S

Subject

Subject means an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control.