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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.

C

Consent

Consent of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her.

Consent is an important element in data protection legislation, as it is one of the conditions that can legitimise processing of personal data. If it is relied upon, the data subject must unambiguously have given his/ her consent to a specific processing operation, of which he/she shall have been properly informed. The obtained consent can only be used for the specific processing operation for which it was collected, and may in principle be withdrawn without retroactive effect.

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