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».

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.   

Documents required for a submission of a clinical trial according to the Clinical Trial Ordinance, ClinO

List of documents required for submissions of clinical trials

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updated: 02.11.2023
Documents required for a submission of a reseach project according to the Human Research Ordinance, HRO

List of documents required for submissions of research projects

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n/a
updated: 02.11.2023

News

The total revision of the Ordinance on the Authorisation of Medicinal Products (AMBV) entered into force on 1st January 2019.

13.03.2019

AMBV Chapter 5 regulates the temporary authorisation for the use of medicinal products in accordance with Art. 9b Para. 1 TPA. The procedures formerly known as "compassionate use" (now temporary authorisation) refer to therapeutic products whose efficacy has already been proven in clinical trials.

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BASEC: Notification of safety events through a new dedicated Safety Form

06.06.2018

The online-platform BASEC (Business Administration System for Ethics Committees) to submit research project has a new feature: there is now a dedicated separate form for notifications of safety events to Swiss Ethics Committees.

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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”.

BASEC

17.12.2015

swissethics wishes to thank all applicants, who already used the new web portal BASEC to submit their new projects. All submissions were received without problems.

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