Downgrade Needs To Be Scheduled Instead Of Nullification

(Doc ID 2278871.1)

Last updated on JUNE 21, 2017

Applies to:

Oracle Argus Safety - Version 8.0.1 and later
Information in this document applies to any platform.

Symptoms

Downgrade E2B and PMDA Form reports are required to be scheduled after Initial E2B was submitted and case Product is changed to another Company Product and Event becomes Non-reportable.
Downgrade E2B and PMDA Form reports should be scheduled in the following SCENARIO-A and SCENARIO-B.


SCENARIO-A:
1) Submit Initial report with Company Product and one Serious Event and one Non-serious Event.
2) Unlock the case as significant follow-up, change the Product to another Company Product, and delete Serious Event only.
3) Auto-schedule. ---> Nullification report for the original Product's license is scheduled. ===> Downgrade is expected.

 

SCENARIO-B:
1) Submit Initial report with Company Product and one Reportable Event.
2) Unlock the case as significant follow-up, change the Product to another Company Product and change Event Causality from Y to N.
3) Auto-schedule. ---> Nullification report for the original Product's license is scheduled. ===> Downgrade is expected.

 

Cause

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