1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Germany in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations applicable to the EU and EEA described in the European Medicines Agency (“EMA”) guidebook. The provisions of the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR 536/2014”), which came into effect in January 2022, may be referred to where national legislation does not specifically address issues.

This guidebook focuses on the procedure to be followed for new clinical trial applications submitted from January 2023 in accordance with the EU CTR 536/2014, supplemented by German laws and regulations, where these are in existence.