BASEC – Submission of Research Projects to Swiss Ethics Committees
News
1.11.2023
The submission forms have been adapted according to the new provisions of the revised ordinances ClinO, ClinO-MD and HRO that came into force on November 1, 2024.
The main changes are:
- Research Project Application Form: screen 2: changes to the ionising radiation section according to art. 36a ClinO and art. 19 HRO. Screen 6: obligation to notify the first patient enrolled in a clinical trial, obligation to publish the lay summary of the trial results (the latter effective as of March 1, 2025).
- Research Project Application Form for Medical Devices / In Vitro Diagnostic Medical devices: screen 2: changes to the ionising radiation section according to art. 14 ClinO-MD, and sharper distinction with new questions for the submission of combined trials with devices and IMPs, and companion diagnostic trials (CDx). Screen 6: new section for IMP for combined trials and CDx trials, obligation to publish the lay summary of the trial results (the latter effective as of March 1, 2025).
- Safety notification and reporting: screen SAE: removed the requirement to notify SAE in clinical trials with IMPs.
Due to changes in the application forms, some of them substantial, it may be necessary to re-upload some documents in section “Ionising radiation” on screen 2 (this is especially true for projects submitted but not yet approved as of 1.11.2024).
Earlier news are available on swissethics.ch (DE, FR, IT, EN).
Read before you start:
- This site is intended to optimize the submission process by guiding you in the description of your project throughout several preformatted screens.
- A short guide how to use BASEC is available here. Additionally, each screen of the submission forms contains specific instructions.
- 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.
- 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 [email protected] 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.
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