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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.

P

Pseudonymisation

Pseudonymisation is a process that allows to switch the original data set (for example data subjects' e-mail or a name) with an alias or pseudonym. Pseudonymization is a reversible process, that de-identifies data but allows the reidentification later on if necessary. The personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person.