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Abstract/Summary
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In view of the impact of the pandemic on European healthcare systems, the European authorities published a guidance document on 20 March 2020. This guidance provides sponsors with recommendations for actions regarding clinical trials and the people involved in them. The guideline can be found on the homepage of the European Medicines Agency (EMA) as well as in the European Commission's legal collection (Eudralex, Volume 10) . Although the guideline consists of harmonised recommendations at EU level, which is co-developed and fully supported by Germany, there are specific national laws and guidelines in many EU member states, including Germany, regarding certain topics in clinical trials that must be taken into account and may take precedence over the European recommendations. Therefore, such areas require closer consideration and interpretation. These topics include, in particular, temporarily applicable measures for source data verification, if on-site monitoring at trial sites is not indicated owing to the COVID-19 (coronavirus) pandemic, and the shipment of investigational medicinal product (IMP) to the trial subject, in case IMP distribution to the trial subject at the trial site is not possible.
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