Encyclopedia

Germany and Austria both have laws regulating the trade of medicinal products. The primary objective of the legislators when enacting these laws is to ensure that only medicinal products that have been proven to be harmless and safe and of a certain quality were put on the market. Furthermore, the laws regulate areas such as…

In accordance with ICH-GCP, monitoring is an essential part of clinical trials and serves their quality control. The Clinical Research Associate (CRA) regularly reviews the rights and safety of patients enrolled, the validity of collected data, the conduct in accordance with the protocol and the GCP, and the adherence to laws and regulations. After each…