What is Non-interventional observational study?
Non-interventional observational study definition and meaning on Health terms:
In epidemiology and statistics, an observational study draws conclusions about the possible effect of a treatment on participants, where the assignment of participants into a treatment group versus a control group is outside the control of the investigator. In a non-interventional observational study, no additional diagnostic or monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collected data (as per Article 2(c) of 2001/20/EC). It is not a randomised, controlled trial (RCT). However, in some cases, observational studies are the most appropriate design