News
Notification of safety events through a new dedicated Safety Form
06.06.2018
Starting June 11, 2018, all notifications of safety events (SE/SAEs, SUSARs, DSUR/ASR, urgent safety notifications, other safety notifications) must be done exclusively through the new Safety Form. This also includes the submission of documents that contain information which reveals treatment assignment in a double-blind study. The submission of safety reports by email or through the main application form will no longer be accepted.
Please read the corresponding FAQ on how to use the new Safety Form before submitting any safety document. Failure to comply with the instructions may result in inspection findings.
The safety form is available under “submit an application / forms available”.
General Data Protection Regulation, GDPR
23.05.2018
On 25.5.2018 the European Data Protection Regulation (GDPR) comes into force. swissethics has therefore updated the legal disclaimer (available in German and French).
RoPS (Registry of ongoing Projects in Switzerland)
11.05.2018
RoPS (Registry of ongoing Projects in Switzerland) is the new registry of all research projects approved by the ethics committees and ongoing in Switzerland, for the general public.
Read moreGeneral Data Protection Regulation (GDPR), also relevant for Switzerland
17.04.2018
On 25 May 2018, the new General Data Protection Regulation (GDPR), will enter into force in the EU, which will also require immediate action in Switzerland for further, smooth international data traffic. In Switzerland, the Federal Act on the Data Protection (FADP, SR 235.1) is currently under revision. Various cantons will also adapt their data protection legislation.
Read moreAmendment to Annex I of the Clinical Trials Ordinance (ClinO) as of 1 May 2017
01.05.2017
The ICH-GCP Guideline of 10 June 1996 was amended by the International Harmonization Conference on 9 November 2016.
Read more