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J5 Was Increased When ACK For Previous E2B Was ERROR (Doc ID 2159372.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 7.0.5 and later
Information in this document applies to any platform.

Symptoms

Observed results: (Issue)
Increased J5 was populated on follow-up E2B when ERROR ACK (:(A.1.6=02, B.1.8=02) or (A.1.6=03, B.1.8=02)) is received for previous E2B submission.

Expected results:
Same J5 was populated on follow-up E2B as previous E2B submission when ERROR ACK is received for previous E2B submission.

Reproduce Step
1) PMDA E2B report was generated with 'Mark as Submitted' checked.
2) ERROR ACK (:(A.1.6=02, B.1.8=02) or (A.1.6=03, B.1.8=02)) was imported.
3) Case was unlock with significant check-box and follow-up information was entered.
4) PMDA E2B report was scheduled and J5 was confirmed. J5 was incremented. << Issue >>



Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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