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Unnecessary 2nd Downgrade is Scheduled if Previous Downgrade Happened as Amendment - E2B R3 (Doc ID 2915078.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.2.1 and later
Information in this document applies to any platform.


An unnecessary 2nd Downgrade is scheduled for an E2B R3 Report if the previous downgrade happened as an Amendment

Steps to reproduce:

  1. Process the initial workflow cycle for a case that qualifies for an E2B(R3) report to Agency A, lock and auto-schedule reports
  2. Submit the initial report to Agency A
  3. Unlock, process significant amendments and change case data so that the case will no longer qualify for a report to Agency A. Lock case, auto-schedule reports.
  4. Initial (A1) was scheduled as a Downgrade report (submit notes containing Downgrade and Amendment) for Agency A. Submit the report.
  5. Unlock, process significant follow-up (don't change other data, the case must still not qualify for a report to Agency A), lock case, and auto-schedule reports.
  6. F/U#1 was scheduled as another Downgrade report --> This is the issue. That second Downgrade is not necessary, since the Downgrade was already scheduled in the previous workflow cycle, see step 4).

This issue leads to unnecessary report submissions and might also lead to late reports (because it can happen that the case priority of the workflow cycle after the downgrade cycle no longer follows 15 days timeline).


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