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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.

R

Right of access

The right of access is the right for any data subject to obtain from the controller of a processing operation the confirmation that data related to him/her are being processed, the purpose(s) for which they are processed, as well as the logic involved in any automated decision process concerning him or her.

This right also allows the data subject to receive communication in an intelligible form of the data undergoing processing and of information regarding the processing.

This right can be exercised without constraint, at any time within 1 month  from the receipt of the request, and is free of charge (Article 14 of Regulation (EU) 2018/1725).

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