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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.

L

Legally designated representative

Legally designated representative, in the context of clinical trials, means a natural or legal person, authority or body which, according to the law of the State concerned, is empowered to give informed consent on behalf of a subject who is an incapacitated subject or underaged.