Seriousness Criteria Check boxes (Section B2) in US Medwatch Drug Form do not Populate if Causality is set to Not Reportable

(Doc ID 989671.1)

Last updated on JANUARY 15, 2010

Applies to:

Oracle Argus Safety - Version: 5.0 to 5.1 - Release: 5 to 5
Information in this document applies to any platform.


Issue Description: Seriousness Criteria Check boxes ( Section B2) in US MedWatch Drug form do not populate if Causality is set to Not Reportable.

Steps to repeat:
1) Bookin a serious case in Argus Safety with Hospitalization check box checked and with hospitalization details duly filled in.
2) Go to Case Event Assessment and set the As Determined Causality as 'Not Related’, As reported causality can be any value.
3) Save the case
4) Schedule a MedWatch drug report and view the draft report
5) Observe that none of the seriousness criteria check boxes are checked in Section B2.
6) Go to Case Event Assessment and set the As Determined Causality as ‘Almost Certain’, As reported Causality can be any value and save the case
7) View the MedWatch Drug Draft Report again.
8) Observe that Hospitalization seriousness criteria check box is checked in Section B2.


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