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Changing The Listedness In Worklist -> Local Labeling Deletes Generated Downgrade Reports (Doc ID 1298109.1)

Last updated on AUGUST 09, 2022

Applies to:

Oracle Argus Safety - Version to 5.1.1 [Release 4.2.0 to 5.1]
Information in this document applies to any platform.


In the following scenario, if the 'Local Labeling Report Scheduling' service is running, a generated, downgrade report will be deleted:

  1. Confirm that a US Marketed Drug expedited rule for CIOMS-I exists for Case Serious = Yes. (see Figure 1)
  2. Confirm that LAM Local Labeling is set to "Re-evaluate generated reports". (see Figure 2)
  3. Create a US case as spontaneous, medically significant with a product that has no assigned datasheet.
  4. In the Analysis tab set Case Serious to Yes.
  5. Click on the Regulatory Reports tab and click on the auto-schedule button.
  6. Lock the case, generate the CIOMS-I report and route the report to SUBMITTED. 
  7. Unlock the case and change Case Serious to No.
  8. Lock the case and click on the auto-schedule button.
  9. Generate the downgrade report.
  10. Close the case and open Worklist --> Local Labeling
  11. Change the listedness from Unknown to Unlisted and process the changes
  12. Open the case and confirm that the downgrade report has been deleted.




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