Switzerland

DCT Feasibility Assessment Switzerland The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaime...

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...

2.1 Name of Regulatory Authority Swissmedic – Swiss Agency for Therapeutic Products. 2.2 Name of Ethics Committee Swissethics - the Swiss Association of Research Ethics Committees. 2.3 Clinical Trial Application Language ...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   Below is a summary of the application documents to be submitted. For full details, see An...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  See Annex 4 of the Clinical Trials Ordinance (ClinO) – here are the main  categor...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   Although it is not 100% clear, it would appear necessary for the PI/CI to be approved/registered in accordance with national require...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to Section 2.7 of this guidebook. No export license is required. 6.2 Does local regulation require any separate consent fo...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/ guidance on the use of DCT eleme...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   In Switzerland, the processing of personal and health-related data is subject to the Federal Data Protection Act (FD...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? So far as we have been able to determine, digital advertisements are allowed....

10.1 Clinical Trial with Investigational Medicinal Product See Section 13 of this guidebook - Appendix 1 . 10.2 Pediatric Investigation Plan (PIP) For an application for a Marketing Authorization, a PIP is required – see Art 54. a of...

Swiss Authorities Swissmedic (Health Authority) https://www.swissmedic.ch/swissmedic/en/home.html   Swissethics (Swiss Association of Research Ethics Committees) https://swissethics.ch/en/ Federal Office of Public Health (FOPH): ...

Forms Please refer to: Swiss Medic’s Clinical Trial Application page which contains a link to relevant forms and checklists. BASEC (Business Administration System for Ethics Committees ) which links to BASEC and includes FAQs and links...