Starting from January 1st 2016 the online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees is mandatory.
No submissions or updates outside of BASEC will be accepted. The check-lists and the “old” base-form will be obsolete and replaced entirely by the online-form in BASEC (Research Project Application Form).
Submission of updates and new documents for projects (amendments, safety-reports etc.):
- Projects that were initially submitted before BASEC: As of January 1st 2016 there will be an additional simplified online-form in BASEC to submit updates to these projects.
- Projects that were initially submitted through BASEC: Updates are submitted through the existing form of your project (see also this FAQ article)
From January 1st BASEC will also offer a form to submit “clarifications of responsibility” to Ethics Committees.
The upload of documents on infrastructure and “staff list” is now optional to reduce the administrative burden for many projects. In special cases the Ethics Committees shall still have the right to ask for documentation on infrastructure and qualifications of staff members at the research site.
Acknowledgement: Mark Heinemann, Principal NIS Specialist, Late Stage, inVentiv Health Clinical