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EVAERS Negative ACK (Doc ID 2895258.1)

Last updated on MARCH 13, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.2 and later
Information in this document applies to any platform.

Goal

FDA Center for Biologics Evaluation and Research (CBER) has changed their validation, so that in order for the elements below (+ Vaccination at Military Site) to be accepted, they have to be populated for the first product in the eVAERS (i.e. The suspect vaccine must be the 1st product).

Currently the eVAERS logic does not mandate this and Argus Safety (AS) does not provide this automatically.

There is an awkward workaround: when there is an eVAERS report the vaccine can be manually made the #1 product.

It would be better if AS did this automatically.

 

Solution

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In this Document
Goal
Solution
References


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