Encyclopedia

Observational studies are non-interventional studies. Usually they are conducted by pharmaceutical manufacturers for their approved medicinal products. During the course of an observational study data of a large number of patients is collected and evaluated, for example data concerning the use by the patient. An observational study is a good way to evaluate the treatment…

In clinical trials, one differentiates between certain kinds of monitoring: On-site monitoring, remote monitoring, and risk-based monitoring. The most frequently conducted kind is on-site monitoring. For that, the Clinical Research Associate (CRA) needs to be present at the study site. By means of source data verification (SDV) and revision of the investigator site file (ISF),…