In the NDA report under section Tabulation by SOC of All Events Reported should all Event Types be counted ?
(Doc ID 1354218.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 6.0 and laterInformation in this document applies to any platform.
Goal
In the NDA Periodic Report - Tabulation by SOC of All Events Reported - should symptoms that have been subsumed under a diagnosis appear and be counted?
Solution
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In this Document
Goal |
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