How to submit a new investigational site to an approved study.
The notification to open a new research site must be submitted to the Lead ethics committee as a substantial amendment.
- go to your account-->manage my applications,
- find the project you want to update and click on Update,
- go to Screen 1. Basic project info,
- scroll down to 'How many research sites in Switzerland are involved in the project?'
- from the drop down menu select 'several sites in Switzerland',
- At the question 'Region(s) of responsibility for additional research sites' select the ethics committee that is competent for the new research site. If the lead ethics committee is also competent for the new research site, select it again. Which ethics committee is competent for which Canton is given here,
- go to the one screen from 7 to 13. additional sites, that correspond to the ethics committee competent for the new research site,
- follow the instruction give in the corresponding screen 7-13. Answer the question and upload the site specific documents,
- go to Screen 14. Submission Summary, tick the checkbox 3.1. Substantial, amendment: addition of new site(s). If necessary, enter a comment in the dedicated field,
- click submit at the bottom of the screen 14.