non-interventional study

A clinical study in which the medicinal product of interest is prescribed in accordance with the terms of marketing authorisation. Assigning a subject/patient to a particular therapeutic arm is not decided in advance by a protocol but falls within current practice; prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are used, and epidemiological methods are used to analyse the collected data.

单词	non-interventional study
释义	non-interventional study non-interventional study A clinical study in which the medicinal product of interest is prescribed in accordance with the terms of marketing authorisation. Assigning a subject/patient to a particular therapeutic arm is not decided in advance by a protocol but falls within current practice; prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are used, and epidemiological methods are used to analyse the collected data. AcronymsSeeNIS
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