BASEC
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».
Link to BASEC (log in page)
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
News
In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC
16.05.2022
On May 26, 2022, the In Vitro Diagnostic Medical Device Regulation (IVDR at EU level) and in Switzerland the revised Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on IVD performance studies.
Read moreThe Medical Device Regulation (MDR) in the EU and the Ordinance on clinical trials with medical devices (ClinO-MD) in Switzerland came into force
26.05.2021
The Medical Device Regulation (MDR) in the EU and the Ordinance on clinical trials with medical devices (ClinO-MD) in Switzerland came into force today, May 26, 2021.As of today, all new clinical trials with medical devices must be submitted to the Ethics Committee using the new submission form “RESEARCH PROJECT APPLICATION FORM FOR MEDICAL DEVICES”, which meets the requirements of MDR and ClinO-MD.
Clinical trials with medical devices: Expected changes in the legal requirements and BASEC
16.03.2021
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 moreClinical trials with medical devices: Expected changes in the legal requirements and BASEC
16.03.2021
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.
If you are planning to submit a new clinical investigation with a medical device before May 26, 2021, or if you currently have a clinical investigation with a medical device under review by the ethics committee, we strongly advise you to read on the swissethics.ch website how the transition of such investigations is to be regulated.
Weblinks to the instructions in English, German, French and Italian on the swissethics.ch website.
Weblink to the newsletter of April 1st 2021.
Updated submission Form “RESEARCH PROJECT APPLICATION FORM”: New question on the declaration of interests of the principal investigator(s)/institution(s).
13.07.2020
A question on ‘declaration of interests’ of the principal investigator(s)/institution(s) has been added to the form for the submission of clinical trials and research projects. The question is mandatory for all new submissions and for already approved/ongoing clinical trials and research projects. If the question is not answered, the form will display an error on screen 14 preventing the submission of the amendment/changes.
Read more