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links to websites of the ECs:

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Home  |   Submit an application  |   My account


BASEC – SUBMISSION OF RESEARCH PROJECTS TO SWISS ETHICS COMMITTEES

(BASEC = Business Administration System for Ethics Committees)

 

News

27.4.2022

Clinical trials with in-vitro diagnostic products: changes in the legal
requirements and BASEC

The legal requirements for clinical trials with in-vitro diagnostic products
(IVDs) in Switzerland are changing. Swiss legislation is adapting to the new EU
regulation on IVDs (In Vitro Diagnostics Regulation, EU-IVDR), namely, clinical
research with IVDs in Switzerland will be regulated in the Ordinance on clinical
trials with medical devices (ClinO-MD) starting May 26, 2022.
Consequently, submission to the ethics committee of new clinical trials with
in-vitro diagnostic products after May 26, 2022, must be done through the form
«Research Project Application Form for Medical Devices and In-Vitro Diagnostic
Products», ONLY.

7.2.2022

Research projects involving human embryonic stem cells (projects of human
embryonic stem cells from surplus embryos) are regulated in Switzerland by the
Stem Cell Research Act (StRA). As of today, all new research projects involving
human embryonic stem cells must be submitted to the Ethics Committee using the
submission form “RESEARCH PROJECT IN ACCORDANCE WITH THE STEM CELLS RESEARCH ACT
(StRA)”.

26.5.2021

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.

16.3.2021

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.
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.
 

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)

 

Technical requirements:

 * Browser: Recent version of Edge, Chrome or Firefox. Internet Explorer 11 or
   below is not recommended.

 

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