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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.

F

Fairness and Transparency

Fairness and Transparency mean that data subjects must be aware of the fact that their personal data will be processed, including how the data will be collected, kept and used, to allow them to make an informed decision about whether they agree with such processing and to enable them to exercise their data protection rights. Consent notices should not contain unfair terms and supervisory authority powers should similarly be exercised fairly.

Fairness and transparency are two of three requirements established by the General Data Protection Regulation for the processing of personal data. Personal data shall be processed lawfully, fairly and in a transparent manner in relation to the data subject. These three requirements are part of the data protection principles.

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