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Same J1 and A.1.0.1 was generated After Nullification (Doc ID 2160278.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 7.0.5 to 7.0.7 [Release 7.0.0]
Information in this document applies to any platform.

Symptoms

We generate PMDA E2B Report after Nullification report, then we found that exact same safety report ID(J1 and A.1.0.1) was generated as the Nullification report.

Expected behavior is that different safety report ID is generated after Nullification.

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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