Last updated on JUNE 01, 2016
Applies to:Oracle Argus Safety - Version 220.127.116.11D to 5.1.1 [Release 4.2.0 to 5.1]
Information in this document applies to any platform.
***Checked for relevance on 30-Sep-2014***
In the following scenario, if the 'Local Labeling Report Scheduling' service is running, a generated, downgrade report will be deleted:
- Confirm that a US Marketed Drug expedited rule for CIOMS-I exists for Case Serious = Yes. (see Figure 1)
- Confirm that LAM Local Labeling is set to "Re-evaluate generated reports". (see Figure 2)
- Create a US case as spontaneous, medically significant with a product that has no assigned datasheet.
- In the Analysis tab set Case Serious to Yes.
- Click on the Regulatory Reports tab and click on the auto-schedule button.
- Lock the case, generate the CIOMS-I report and route the report to SUBMITTED.
- Unlock the case and change Case Serious to No.
- Lock the case and click on the auto-schedule button.
- Generate the downgrade report.
- Close the case and open Worklist --> Local Labeling
- Change the listedness from Unknown to Unlisted and process the changes
- Open the case and confirm that the downgrade report has been deleted.