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This important module tracks an SAE from its identification to submission to applicable agencies
The ability to submit a variety of forms, including CIOMS and MedWatch is available. Track every submission to any agency in one easy location. And all notifications happen in real-time, and are auto-generated based upon data entry.
AE/SAE tracking and management handled by Fusion:
– All SAEs are submitted by clinical sites to Axiom PV / Sponsor via Fusion
– Safety Team may request additional information based upon the AE/SAE information as required for reporting purposes
– Notifications are auto-generated based upon data entry