1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Spain in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations and guidance applicable to the EU and EEA described in the European Medicines Agency (“EMA”) guidebook. The directives of the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR”), which came into effect in January 2022, are implemented in individual countries through national legislation. Where national legislation has not yet been effected, the provisions of the EU CTR may be referred to. There is an exception to this as, until January 2023, the provisions of the Clinical Trials Directive 2001/20/EC (“CTD”), which have been replaced by those of the EU CTR, were applicable to clinical trials in certain instances as described in this workbook.

In Spain, the EU CTR has been adopted through the Royal Decree 1090/2015, of December 04, 2015 (“RD 1090/2015”). This national legislation is to be read along with the provisions of the EU CTR to obtain a full understanding of the subject matter at hand.