November 28, 2019. Draft Q&A document v2.3 available: Clinical Trials Regulation (EU) no. 536/2014. |

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

Draft Questions and Answers Document (Version 2.3) (Eudralex Volume 10 – Clinical trials guidelines – Set of documents applicable to clinical trials under Regulation EU No 536/2014).