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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.

I

Incapacited subject

Incapacitated subject means a subject who is, for reasons other than the age of legal competence to give informed consent, incapable of giving informed consent according to the law of the State concerned.