1. Executive Summary

This workbook provides an overview of the current and proposed regulatory landscape applicable in Switzerland in relation to Decentralized Clinical Trials (“DCT”) with medicinal products through Swissmedic (the CA/RA) and Swissethics (the Swiss Association of Research Ethics Committees).

In Switzerland, research involving humans is governed by the Human Research Act (“HRA”) and its implementing ordinances. Switzerland was one of the first countries in Europe, along with Sweden and Denmark, to publish position papers on Decentralized elements in clinical trials with medicinal products.

Disclaimer: The three main national languages of Switzerland are German, French and Italian. In this guidebook, we quote, refer to and link to informal English translations of a number of documents, including local laws (mainly provided by the Swiss government via their websites). These informal English translations have no legal force.