Unable To Generate E2B Report In Argus-Japan
(Doc ID 2226164.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.0 and laterInformation in this document applies to any platform.
Symptoms
On : 8.0 version, Reports - Expedited
ACTUAL BEHAVIOR
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Unable to generate PMDA E2B report with PMDA ICSR validation report showing that mandatory data element B.4.k.2.1 is not fulfilled when the J Product Code is set to a digits less than 9.
EXPECTED BEHAVIOR
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PMDA E2B report should able to be generate if the B.4.k.2.1 data element is already filled.
STEPS
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The issue can be reproduced at will with the following steps:
Settings:
1. Go to Argus Console > Business Configuration > Products and Licenses.
2. Create product A with J Product Code less than 9 digits (example: 1234567)
Steps:
1. Book in a new case form and apply Product A in the case.
2. Fill in all PMDA mandatory fields.
3. Go to Regulatory Reports tab. Schedule an E2B report to PMDA agency.
4. Attempt to open the report by clicking on the DRAFT hyperlink.
Changes
Cause
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In this Document
| Symptoms |
| Changes |
| Cause |
| Solution |