Non-Interventional Studies (NIS)

Non-Interventional Study or Non-Interventional Trial: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data (as per Article 2(c) of 2001/20/EC ).

NISNon-interventional studies (NIS), such as observational studies, play an important role in the development and life-cycle management of medicinal products.  Unlike clinical trials, NIS (especially those studies which are not post-authorisation safety studies) are less clearly and uniformly regulated.

CHCUK provide a range of tools and services which aim to help you understand the regulatory framework(s) within which NIS currently sit e.g., regulatory maps capturing the regulations and guidelines applicable to specific regions.

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