The Export Logic For The EVAERS Element <seriousnesservisit>
(Doc ID 2019929.1)
Last updated on DECEMBER 03, 2019
Applies to:Oracle Argus Safety - Version 8.0 and later
Information in this document applies to any platform.
For the eVAERS element the FDA rules state that :
VAERS regional terminology used to further clarify AE Outcome using code: C53513. Regional conformance is required and has a dependency with AE Treatment Facility information.
Could you please explain how does the business logic for the export of this element satisfy this requirement/ or can be modified to satisfy this requirement?
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