BASEC (Business Administration System for Ethics Committees) is the portal for the submission to the ethics committees: clnical trials, research projects, amendments, notification of safety events, clarification of responsibilities, requests for temporary autorizations, general questions, etc.
BASEC is not an electronic repository (Archiv) for study documents. Consequently, drafts that are not submitted, are deleted after 6 months inactivity.
Therefore, it is required that the sponsors and investigators regularly save and archive the study documents, as well as the letters and emails received from the ethics committee, on their own IT-infrastrukcture.
Detailled information on how to use BASEC can be found in BASEC itself and on the page «Frequently Asked Questions».
List of documents required for submissions
Note: The BASEC-submission-form will automatically ask for the documents required according to the selection of the project-type. This document is given here for reference only.
List of documents required for submissions of clinical trials
List of documents required for submissions of research projects
Clinical trials with medical devices: Expected changes in the legal requirements and BASEC
On May 26, 2021, the Medical Device Regulation (MDR at EU level) and in Switzerland the Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on clinical investigations with medical devices, including investigations on proof of efficacy and safety of medical devices. Hence, many additional documents must be submitted to the ethics committees.Read more
Implementation: guiding principles for registers in human research
Advisory opinion of the ethics committees on registers, biobanks and research projects in accordance with Art. 51 HFG
The pure creation of data registries or biobanks is not formally subject to authorisation under the HRA. However, projects that re-use these data and biological samples must generally be approved by an ethics committee. The ethics committees now offer a preliminary examination of the data registries and biobanks.Read more
Information on the coronavirus
Sponsors, investigators and project leaders of clinical trials and research projects in Switzerland must ensure that the studies are conducted in line with the COVID-19 Ordinance 2 (available in German (PDF), French (PDF) and Italian (PDF), issued by the federal government on 16 March 2020.
In particular, participants over the age of 65 and participants with underlying medical
Information on the corona virus
virus also does not stop at the ethics commissions. Not all the scheduled
committee meetings can be held regularly at the various locations. This means
that there may be delays in the decision-making process and therefore deadlines
cannot always be met. The ethics committees thank you for your understanding.
Nevertheless, the reviews and approvals of studies investigating the disease or investigational medicinal products for COVID-19 are of course treated with priority.
We thank you for your cooperation in this critical situation. In individual cases, the ethics committees are available to answer questions on this matter directly.
Temporary authorisation to use medicinal products in accordance with Article 9b para. 1 TPA
The total revision of the Ordinance on the Authorisation of Medicinal Products (AMBV) entered into force on 1st January 2019.Read more