Switzerland

Switzerland

Swiss National Clinical Trials Portal (SNCTP)

Verified on June 24, 2022

Switzerland has a supplementary federal database, Swiss National Clinical Trials Portal (SNCTP). The regulation requires that sponsors must register their protocol in a World Health Organization (WHO) primary registry or ClinicalTrials.gov. SNCTP is not a WHO recognized primary registry. The sponsors must register the additional information than what is posted on WHO primary registry or ClinicalTrials.gov, in a Swiss national language on SNCTP as per Ordinance on Clinical Trials in Human Research. Posting protocol registration in SNCTP is mandatory. There is no provision for posting results.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
SNCTP National- or Registry that Supplements information from other Registries Sponsor Clinical Trial Application

Interventional

(phase 1 to 4)
German
French
Italian
English
BASEC Mandatory National Database (includes Ethics Requirement) Ethics Clinical Trial Application

Interventional

(phase 1 to 4)
German
French
Italian
English
ClinicalTrials.gov Country requiring/recommending ClinicalTrials.gov use Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

phase 2-4
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
SNCTP Registration

Yes

Phase 1 clinical trials: Up to 1 year after the completion of the clinical trial. Phase 2 to 4 clinical trials: Before the clinical trial starts.
Results

n/a

Not applicable (NA)
BASEC Registration

Yes

Phase 1 clinical trials: Up to 1 year after the completion of the clinical trial. Phase 2 to 4 clinical trials: Before the clinical trial starts.
Results

No

NA
ClinicalTrials.gov Registration

Yes

Phase 1: voluntary; Phase 2-4-Within 21 days of first patient enrollment
Results

Yes

Primary Results - within one year of primary completion date (PCD); Subsequent Results - within one year of the last subject last visit for each secondary outcome measure (SOM); Final Results - within one year of the study completion date

Registry Updates


  • May 2022: Switzerland Update - An update posted on the Kofam portal on May 27, 2022, informs users of the most important new developments and changes relating to clinical trials with in-vitro diagnostic products (IVDs) which  are regulated by the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) from May 26, 2022. According to the update, in addition to the existing … Continue reading "May 2022: Switzerland Update"
  • May 2022: Switzerland Update - An update posted on the SwissMedic portal on May 26, 2022, informs users of the change in legal requirements for clinical trials with in-vitro diagnostic products (IVDs) in Switzerland. From 26 May 2022, at the same time as the application of the In Vitro Diagnostics Regulation (IVDR) in the EU, clinical trials with in vitro … Continue reading "May 2022: Switzerland Update"
  • Switzerland Update - An update posted on the Kofam portal on March 10, 2022, informs users of the change in legal requirements for clinical trials with in-vitro diagnostic products (IVDs) in Switzerland. Clinical trials using IVDs, a special sub-group of medical devices, were regulated in the Clinical Trials Ordinance, (ClinO).  In the process of adapting the Swiss legislation … Continue reading "Switzerland Update"

References


  1. Ordinance on clinical trials with medical devices. https://www.fedlex.admin.ch/eli/cc/2020/553/de#chap_5. Published July 01, 2020. Accessed June 14, 2021.
  2. Medical device regulation. https://www.fedlex.admin.ch/eli/cc/2001/520/de. Published October 17, 2001. Accessed June 14, 2021.
  3.  New regulations for clinical trials of medical devices (admin.ch)
  4. SR 810.306 – Ordinance of 1 July 2020 on Clinical Trials with Medical Devices (CTO-MedD) (admin.ch)