BASEC – Submission of Research Projects to Swiss Ethics Committees

News

6.2.2025

The screen 4. SNCTP in the submission forms will be updated on March 1, 2025, according to the new provisions of Chapter 5 of the revised ordinances ClinO, that come into force on March 1, 2025. The portal SNCTP, which is operated by the FOPH, will be renamed «HumRes», and screen 4. in the submission forms is then renamed accordingly.
 
The main changes of the revised Chapter 5 ClinO include: obligation to publish the data specified in Annex 5 ClinO in the portal «HumRes» in the Swiss national languages in which recruitment is planned and the obligation to publish a lay summary of the trial results at least in those national languages of Switzerland in which persons were recruited.
The data is entered in screen 4. HumRes and automatically transferred and published on the portal «HumRes» after the ethics committee has granted approval for the clinical trial. For Phase I clinical trials in which the medicinal product under investigation is administered exclusively to adults, some of the data may initially be excluded from publication.
 
Due to these changes to the submission form, applicants of clinical trials may need to update the trial data in screen 4. HumRes with the next submission.  Details on the new process will be available in the new screen 4. HumRes.

1.11.2024

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 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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