Submission of safety reports (SUSARs, SAEs, ASR/DSUR etc.)
This procedure is effective from 11 June 2018!
How do I use the safety form? How do I submit safety reports, like SUSARs, SAEs, ASR/DSUR, etc. or notify the EC of immediate safety and protective measures?
The safety form is used exclusively for the submission of any safety reports (SUSARs, SAEs, SEs, Annual Safety Reports (ASR) / Development Safety Report (DSUR), etc.) and for the notification of immediate safety and protective measures to the EC. The submission of safety reports by email or through the main application form is not accepted.
The owner of the safety form can be different from the owner of the main application form. For example: The owner of the safety form can be the dept. pharmacovigilance while the owner of the main application form can be the dept. of clinical operations, the coordinating investigator, etc.
In a double-blind study, where SUSARs and other safety documents may contain information that reveals treatment assignment, the owner of the safety form must be a member of the 'unblinded team'. See below: Information about the submission of unblinded data, for more information.
There can be one safety form per project only. Once a safety form has been created and linked to the project, by entering the unique project BASEC or Pre-BASEC(*) ID number in the appropriate field, the same safety form must be used throughout the study for the submission of safety reports and immediate safety and protective measures.
(*) If the study is a pre-BASEC multicenter study without a Lead-EC, the owner of the safety will need to open as many safety forms as the number of ECs competent for the study and link them, each one individually, to the corresponding competent EC.
Any updated non-safety documents (e.g. the 'patient information and declaration of consent') must be submitted to the EC using the main application form (see this article for the submission of amendments and new documents), while the safety report must be submitted using the safety form.
Do not remove safety documents from an already submitted form! If you need to add new reports / documents, use the link 'add document' / 'add follow-up'.
Always submit the SUSARs, SAEs, etc. sequentially (1) as they occur and do not submit a follow-up of a SUSAR or of an SAE as a new event but add the follow-up to the original SUSAR, SAE, etc. using the link 'add follow-up' (2).
On the last screen 'Submission Summary' fill in / update the field 'Submission details and comments' (1) at the very bottom of the screen anytime before you submit (2).
After the submission, an automatic email acknowledging the reception of the form and safety documents is sent to the owner of the safety form.
How should a follow-up to a SAE or a SUSARS that was submitted before June 11, 2018 (i.e. before the launch of the safety form) be submitted with the new safety form?
If the owner of the safety form or a contributor needs to submit a follow-up to a SAE or a SUSAR, that is not in the safety form, because it was submitted before the launch of the safety form, it must upload the follow-up as a new SAE, resp. a new SUSAR. The owner of the safety form or the contributor should add a comment in the ‘comments’ field in screen 7 ‘submission details’. If there are additional follow-ups to that single case, these will be uploaded as FU1, FU2, …
The owner of the safety form should not re-submit the original SAE, resp. the original SUSAR to the ethics committee through the safety form.
Information about the submission of unblinded data:
SUSARs and DSURs might contain information that reveals treatment assignment in a double-blind study. If this is the case, the owner of the safety form must be a member of the 'unblinded team', i.e. he/she is authorized to see the treatment assignment. The owner of the safety form manages access of other contributors to the safety form or to the individual screens of the safety form by using the functionality 'manage invitation'.
The owner of the safety form must not give access to the 'blinded team' to safety reports (i.e. to the screens) that reveal the treatment assignments.
Request to transfer the safety from one account owner to another
When the account owner asks the EC to transfer the safety form to another account, he/she must always indicate whether the transfer concerns the safety form only, or whether it should include the transfer of the main form. Before requesting the transfer, the account owner must clarify that the treatment assignments in a blinded project are not revealed to unauthorized persons by transferring the safety form from his/her account to a new account.