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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.

A

Anonymization

Anonymized data is personal data that has been rendered anonymous in such a way that the individual is not or no longer identifiable. Thus, through data anonymization techniques, retracing a patient’s identity is no longer possible even indirectly through his / her ID number. Anonymized data can only be found in statistical analysis or aggregate data and are therefore extremely rare in the context of drug development / clinical trial.