Processing Of Follow-Up SAE (Event Is Still Ongoing)

Hello,

May I ask how you process a follow-up SAE where the only update is the fact the event is still ongoing?

Do you send it for a review to clinical reviewer and if it was a SUSAR submit a follow-up report when the only change is the period of time the event has been ongoing.

We had a discussion in our team that potentially the length of the event could affect the causality and expectedness assessment so had some changes in our processes. What is your practice when the site responds that an event is still ongoing and there are no changes to report? Do you have a different process based on whether the event was previously an SAE, SAR or SUSAR?

Thanks,

Marinela Zagorscak

Specialist in Pharmacovigilance and Safety

 Centre for Trials Research

1. Zagorscak

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