Unscheduled PMDA paper report displays in the "Pending by Destination"
(Doc ID 2045386.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 7.0.3 to 8.0.1 [Release 7.0.0 to 8.0]Information in this document applies to any platform.
Symptoms
When viewing the PMDA Paper report (form-1/2) from the draft icon in the toolbar and if there is the PMDA ICSR validation error appears at that time,
this report displays under case revision > report > pending by destination even though the report has not been scheduled yet.
Steps:
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1. Create a new case
2. Enter the mandatory value to display PMDA E2B
3. Save the case
4. Click the draft icon in the tool bar and select PMDA Paper report
5. Confirm that the report displays properly
6. In order to display the PMDA ICSR validation error, remove the value from the mandatory field for PMDA E2B
7. Save the case
8. Click the draft icon in the tool bar and select PMDA Paper report again
9. Confirm that PMDA ICSR validation error appears
10. Go to (menu) case actions > revision histories
11. Navigate to Reports > Expedited > Pending by Destination
This invalid PMDA Paper report is populated even though this report has not been scheduled in the case form > regulatory report tab
Note:
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Every time when clicking the draft link > PMDA Paper report,
the orphan record will be created in cmn_reg_reports table if the report has the PMDA ICSR validation error.
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |
References |