E2B Downgrade Report to PMDA cannot be Generated after Deleting a Reportable Event that was Previously Transmitted/Submitted. (Doc ID 2067875.1)

Last updated on JUNE 23, 2017

Applies to:

Oracle Argus Safety Japan - Version 6.0.2.1 to 7.0.3 [Release 6.0 to 7.0.0]
Oracle Argus Safety - Version 6.0.2.1 to 7.0.3 [Release 6.0 to 7.0.0]
Information in this document applies to any platform.
***Checked for relevance on 23-JUN-2017***

Symptoms

When a reportable event is deleted from a case due to a significant follow-up change, E2b downgrade report to PMDA cannot be generated.

E2B validation check runs for the downgrade report and shows the following errors:

  B.2.i.1.a REACTIONMEDDRAVERSIONLLT
  B.2.i.1.b REACTIONMEDDRALLT
  B.2.i.2.a REACTIONMEDDRAVERSIONPT
  B.2.i.2.b REACTIONMEDDRAPT
  B.2.i.8    REACTIONOUTCOME


Step to Repeat:
1. Login to Argus Safety as Argus Safety Japan user and create a spontaneous case with 2 serious events
2. Schedule an E2b report to PMDA
3, Lock the case, generate the E2b report, transmit it to PMDA and mark it as submitted
4. Unlock the case and add a significant follow-up to the case
5. Delete the 2nd serious event from the case
6. Schedule a downgrade E2b report to PMDA manually
7. Try to view the draft E2b report from regulatory reports
8. Observe that the system gives the E2b validation error.



Cause

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