SAE follow-up reports: updates, resolution, and final outcomes
Maintain the SAE reporting cycle from initial report through follow-up updates to final narrative, tracking open events until resolution and producing comprehensive documentation for regulatory review.
The initial report is not the end
The initial SAE report has been submitted. The 24-hour deadline is met. The coordinator documented the awareness moment, gathered available information, obtained the investigator's assessment -- or submitted with causality pending -- and filed the report with the sponsor before the clock expired.
And now what?