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

Required documents for clinical trials and research projects

Reference list of documents required for submissions.
Please 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.

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updated: 24. 07. 2018


Aktuelles

Temporary authorisation to use medicinal products in accordance with Article 9b para. 1 TPA

13.03.2019

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

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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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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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