ECSubmissionFormat object

Format option(s)

Depending on the Cantonal EC: usually via post on data carrier (CD/USB stick) + x copies in paper format.

Preferred format

BASEC (new web portal): in use since November 2015; Mandatory from 1st of January 2016

Online portal

tarting from November 2nd 2015 all new projects should be submitted through the web-portal. As of January 1st 2016 the online-submission is mandatory and replaces all former submission methods (paper, CD, other storage devices). 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.

Standard application form available

Yes

Standard application form

The standard form (“Basisformular”) and checklist to be bindingly used for submission to the competent EC(s) is available on the Swissethics website in section "Templates".

Use of standard application form binding

Yes

Guidance on submission format

The required application documents for trials with medical devices are provided in Appendix 3 KlinV/ClinO.
They must always be co-signed by the investigator if the sponsor is the applicant.
Further relevant forms, guidelines and checklists for submission are published on the Swissethics website.

Additional Information

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