Human Research Act (HRA) and Clinical Trials in Switzerland

Who authorises a clinical trial?

Always the competent cantonal ethics committee. Additionally Swissmedic, where the trial involves a medicinal product, a medical device or a transplant and falls into a category requiring regulatory authorisation. Both procedures run in parallel and are coordinated.

The classification determines the effort and the timelines. It follows the additional risk the investigational intervention creates compared with standard treatment.

How does the submission process work?

The application to the ethics committee is submitted via BASEC, the Swissmedic application via the Swissmedic Portal. The authorities coordinate with each other. The ethics committee generally decides within 30 days of a complete application, Swissmedic within a comparable timeframe.

1. Determine the category and identify the competent ethics committee.
2. Prepare the trial protocol, investigator's brochure, information and consent documents, and insurance evidence.
3. Submit the application via BASEC, and in parallel to Swissmedic for category B or C.
4. Answer formal review questions and adjust documents.
5. Wait for the authorisations, then register the trial in a recognised registry.
6. Report the trial start and comply with safety reporting and annual reports.
7. Report the end of the trial and the final report.

What duties does the sponsor have during the trial?

It reports serious adverse events within the set deadlines, informs about safety measures, submits annual reports, seeks authorisation for substantial protocol amendments before implementing them, and ensures the trial is conducted under Good Clinical Practice.

• Suspected serious unexpected adverse drug reactions: reported within the deadlines of the Clinical Trials Ordinance.
• Safety and protective measures: immediate report to the ethics committee and Swissmedic.
• Substantial amendments: authorisation before implementation.
• Annual safety report on the trial's course.
• Registration in a primary registry recognised by Switzerland.
• Retention of trial documents for the statutory periods.

What role does swissethics play?

swissethics is the association of the cantonal ethics committees. It harmonises templates, publishes model documents for information and consent, and operates the BASEC portal together with the committees. Authorisation, however, is always granted by the individual competent committee.