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 an applicant/sponsor 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 applicant/sponsor 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, …
There is no need for the applicant/sponsor to re-submit the original SAE, resp. the original SUSAR to the ethics committee through the safety form.
In this way you will still be able to follow up any safety case individually until its closure.
The FAQ in front-end has been updated accordingly.