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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

Clinical Study

Clinical study means any investigation in relation to humans intended:

(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;

(b) to identify any adverse reactions to one or more medicinal products; or

(c) to study the absorption, distribution, metabolism and excretion of one or more medicinal products;

with the objective of ascertaining the safety and/or efficacy of those medicinal products.

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