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

Last updated on MARCH 08, 2017

Applies to:

Oracle Argus Safety - Version 7.0.2 and later
Information in this document applies to any platform.

Goal

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).

Solution

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