How To Setup Reporting Rules For Initial Case Which Is A Death Case And Reportable In 7 Days To FDA?
(Doc ID 1374735.1)
Last updated on APRIL 22, 2021
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.
***Review currency on 06-Feb-2015***
***Reviewed for currency: 15-AUG-2017***
Need to setup Expedited Reporting Rule for business requirement as follows
1. Initial Case is death case and should be reportable in 7 days to FDA and subsequent follow-up to same case should be reportable in 15 days to FDA.
2. Initial case is not death case and reportable in 15 days to FDA and if follow-up came as death case then case should be reportable to FDA in 7 days and then sub sequent follow-up should be reportable in 15 days to FDA
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