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Argus Safety E2B Reports Can Be Transmitted After Being Marked as Submission Not Required (Doc ID 2124073.1)

Last updated on JULY 15, 2020

Applies to:

Oracle Argus Safety - Version 7.0.2 to 8.1 [Release 7.0.0 to 8.1]
Information in this document applies to any platform.


In Argus Safety, some E2B reports are transmitted even after marking them as submission not required as illustrated by the following example:

In the Case Form > Regulatory Reports tab, click on the E2B report and select View Report Details.

In the Report Details screen > General tab:
- Report Type = E2B
- Date Generated = 03-APR-2015 11:42
- Date Submitted = 06-APR-2015 01:35
- Date Transmitted = 06-APR-2015 01:24

In the Report Details screen > Submission tab:
- Submission Required = No
- Determined On = 06-APR-2015 01:14
- Reason for Non-Submission = Report generated erroneously. Not expedited to FDA.

Note that the value for Date Transmitted is 10 minutes after the value for Determined On (the date when Submission Required = No was selected in the Report Details screen).


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