ECAmendment object

Ethical review mandatory for

Any substantial amendments

Responsible for notification of SA

Investigator

Standard notification form available

Yes

Standard notification form

Submission via the new web portal BASEC

Timeline Ethical review of SA (max nr days)

30 (local EC) + 45 (lead EC)

Guidance on submission of SA available

Yes

Guidance on submission of SA

Detailed Guidance to the use of the new web portal BASEC is available on the website of Swissethics.
Please use these former submission methods for amendments and additions to old projects until December 31 2015; from January 1st 2016 the web-portal will also be compulsory for old projects.

Applicable national legal framework/ Reference

Art. 29 KlinV/ClinO

Additional Information

CAVE: The definition of substantial amendments for ECs is different to the definition for CA!
Other changes must be notified to the EC in the annual safety report.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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