PMDA E2B was scheduled by the unmatched reporting rule
(Doc ID 2096712.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 7.0.6 to 8.1 [Release 7.0.0 to 8.1]Information in this document applies to any platform.
Symptoms
In the reporting rule, the "reporting category" is a blank and the "license category" have been configured.
When run the auto scheduling from the case, PMDA E2B report was scheduled by this reporting rule even though the case has the different "license category" value in Analysis > PMDA Info tab.
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STEPS
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1. Go to Argus Console > business configuration > expedited reporting rule
2. Leave the blank in the "reporting category" and set the "license category""(eg., Not approved)
3. Save the configuration
4. Book a case
5. Enter mandatory information for PMDA E2B
6. Go to Analysis > PMDA Info tab > general tab
7. Set the different license category (eg., Do not apply or leave the blank)
8. Save the case
9. Go to regulatory report and press [Auto schedule]
PMDA E2B scheduled by the reporting rule above event though the conditions of the license category in the reporting rules does not match with the case data.
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |
References |