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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 Trials Information System (CTIS)

The Clinical Trials Information System (CTIS) is a unified European system, which all sponsors must use to obtain the authorization for their clinical trials. The authorization is delivered through the platform by the responsible Member State. This system increases the transparency and availability of information on clinical trials and their results as it makes data accessible to the public.

The CTIS includes the EU portal, the EU Database and a module for the submission of Annual Safety Reports. The EU Portal is the single entry point for the submission of data and documents relating to clinical trials. The EU Database contains data and documents submitted via the EU Portal. A part of this database is publicly available.