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E2b Draft Report Calculates PMDA Report A.1.9 Value Incorrectly (15 Vs 30 Day) (Doc ID 1354987.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 6.0.2.1 and later
Information in this document applies to any platform.

Goal

We have a valid 15 day expedited report for PMDA Japan.

Expedited reporting rule runs fine and calculates the due date at the 15th day from the on-set date by clicking the ‘auto schedule’ button.

Now, when we click the Draft button on the top (Ctrl + Alt + R) , it calculates the A.1.9 (fulfill expedited criteria) = 2 instead of 1.

Please explain why this occurs?


Solution

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In this Document
Goal
Solution


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