Last updated on AUGUST 15, 2017
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
Sign In with your My Oracle Support account
Don't have a My Oracle Support account? Click to get started
Million Knowledge Articles and hundreds of Community platforms