Causality Common Profile Key Causes Reporting Rule To Overreport
(Doc ID 1342809.1)
Last updated on FEBRUARY 22, 2019
Applies to:Oracle Argus Safety - Version 4.2.0 to 7.0.0 [Release 4.2.0 to 7.0.0]
Information in this document applies to any platform.
***Reviewed for currency: 09-JUN-2013***
***Checked for relevance on 16-Sep-2015***
Expedited Regulatory Report Rule is over reporting when the rule configured with Event Listedness as 'Unlisted' and 'As Reported Causality' as '(ignore)' and 'As Determined Causality' as 'Reportable' for Study cases
Steps to Repeat:
1. Configure a reporting rule for Investigational Drug with the following configuration:
1. Listedness (Event) = Unlisted
2. Fatal/Life Threatening = Ignore
3. Serious (Event) = Yes
4. Serioes (Case) = Ignore
5. As Reported Causality (Event) = Ignore
6. As Determined Causality (Event) = Reportable
7. As Reported Causality (Case) = Ignore
8. As Determined Causality (Case) = Ignore
2. Create a serious, unlisted and not reportable (as determined causality) case
3. Click on Auto Scheduling
4. Observe that the system scheduled a report for the above reporting rule even when the event determined causality set to Not Reportable
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