swissethics Newsletter: Safety Form
 

Dear All,

After several months of hard work and the contribution and dedication of many of you, we are now ready to launch the new dedicated Safety Form in BASEC for the notification of all safety events.

Starting Monday June 11, 2018, all notifications of safety events (SE/SAEs, SUSARs, DSUR/ASR, urgent safety notifications and other safety notifications) will go through the Safety Form.

This also includes the submission of documents that contain information which reveals treatment assignment in a double-blind study. The submission of safety reports by email or through the main application form will no longer be accepted.

The applicants, front end users and all those how have registered to the swissethics Newsletter will be informed by a Newsletter shortly. Additionally, we are adding News with links to the FAQ on swissethics.ch and in BASEC.

The safety form has been tested in-depth internally and by front-end users. Thus, although we do not expect any major issue, any launch of a new technical solution and new process goes through a learning curve and bears some risks. For this very reason, please go through the attached FAQs (front and back end) if not done so yet and do not hesitate to contact Michael, Arthur or Pietro for any question you might have or for any help you might need.

Again, many thanks to all of you who have contributed with ideas, suggestions, tests,… to the creation of the safety form.

 

That’s it!