BASEC: Notification of safety events through a new dedicated Safety Form
The online-platform BASEC (Business Administration System for Ethics Committees) to submit research project has a new feature: there is now a dedicated separate form for notifications of safety events to Swiss Ethics Committees.
Starting June 11, 2018, all notifications of safety events (SE/SAEs, SUSARs, DSUR/ASR, urgent safety notifications, other safety notifications) must be done exclusively through the new 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.
Please see this FAQ for more detailed information on how to use the new Safety Form. Further complementary information are also available in BASEC. The new dedicated Safety Form has several advantages, among others:
- One single dedicated Safety Form per project, used for the notification of all safety documents of that specific project.
- The Safety Form will not be locked after a submission. Thus allowing multiple parallel notifications, without any constraints for the researchers, even during the review of the documents by the Ethics Committee.
- The Safety Form can be owned and managed by a different person or team (e.g pharmacovigilance) other than the owner of the main application form. This allows the notification of safety documents that contain information which reveals treatment assignment in a double-blind study, without disclosing the treatment to unauthorized persons.
- Access to the individual screens of the safety form (SE/SAE, SUSAR, …) can be managed per project by the owner of the Safety Form.
- Simple structured screens and sections which allow the applicants to keep track of which safety document and version (first submission, follow-ups) has been submitted throughout the course of the study.