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BASEC – Submission of Research Projects to Swiss Ethical Committees

(BASEC = Business Administration System for Ethics Committees)Login

 

News

13.7.2020

Updated submission Form “RESEARCH PROJECT APPLICATION FORM”: New question on the declaration of interests of the principal investigator(s)/institution(s).

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.

The submitters of approved/ongoing studies are asked to answer the new question exclusively together with the submission of an amendment or other changes to the study. The question on ‘declaration of interests’ should not be answered and submitted separately from the submission of an amendment or other changes.

02.06.2020

New submission Form available: Advice on ethical questions/comments on research projects not subject to the HRA.
Use this form to obtain an advice on a data registry or on a biobank (without a concomitant submission of a research project), or to obtain comments on a research project not subject to the HRA, and specifically projects carried out abroad. The research project must be close to the ethics committee’s area of expertise. The form fulfils the requirements set by Article 51 lit 2 HRA.

24.03.2020

Information on the corona virus

Please consult the dedicated COVID-19 website on swissethics.ch for news on the corona virus, guidance documents on the conduct of clinical trials and research projects in Switzerland, and other information. The COVID-19 website is updated regularly with new information, as it becomes available.

To promote transparency and facilitate the coordination of research on COVID-19, swissethics now publishes all approved and all submitted clinical trials and research projects on the dedicated COVID-19 website. Researchers are kindly asked to find out which projects are already underway in order to avoid national duplications. Should you oppose to that, please contact swissethics at info@swissethics.ch before you submit the project.

13.3.2019

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

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. The therapeutic products show a benefit, but have not (yet) been approved. The approval of the temporary authorisation is issued by Swissmedic. The Ethics Committees give an advisory opinion to the attention of Swissmedic.

Therefore, the sponsors must submit the necessary documents to the Ethics Committees through BASEC using the form ‘Application for a Temporary Authorisation’, before submitting the application to Swissmedic. In the case of multicentric applications, all documents are submitted to the lead Ethics Committee.

6.6.2018

Notification of safety events through a new dedicated Safety Form

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”.

23.5.2018

General Data Protection Regulation, GDPR
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).

 

Please read carefully:

  • This site is intended to optimize the submission process by guiding you in the description of your project throughout several preformatted screens;
  • Each screen contains Help to assist you;
  • Your project is saved automatically and you may return to and work on it again before submitting; Draft projects that were never submitted will be deleted after 6 months of inactivity.
    Please backup and archive your projects on your own IT infrastructure. BASEC is not designed and not intended to be an electronic filing system (archive) for your projects.
  • Reread your project carefully before submitting it. Keep in mind that once your project is submitted, the evaluation begins.
  • Once you have submitted a new project you will receive an email with a unique BASEC ID number for your project. This will confirm you that your project has been received by the ethics committee and the evaluation has started. You will receive a second email within 7 days of submission, once the formal check is completed.
  • For quality assurance purposes, all ethics committees in Switzerland can view and consult the submitted project in BASEC. Should you oppose to that, please contact swissethics at info@swissethics.ch before you submit the project.
  • If you need to send an urgent update and your project is currently locked, please contact the Ethics Committee by email, phone or through the support form in the web-portal. (see also this FAQ-entry)

 

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