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Counting up for M2/J2 safety report version (Doc ID 2009304.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 7.0.4 and later
Information in this document applies to any platform.

Symptoms

In a rare situation that the E2B generation / submission is somehow not working due to system issue.

we will need to submit via paper- i.e. we will generate a report and mark it as submitted, then submit the report via sending the physical copy to PMDA.

In that case, when we receive a follow-up information later on and the schedule the follow-up report,

E2B M2/J2 - safetyreport version- displays as 1 and does not count it up.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution


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