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Non Reportable Event Name Populates In PMDA E2B R3 INV J2.11 (Doc ID 2983697.1)

Last updated on OCTOBER 31, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.2.3.2 and later
Information in this document applies to any platform.

Symptoms

The case has the event with the "Do not include in the report(報告対象に含まない)" flag. This means is that this is non-reportable event.

When viewing PMDA E2B R3 INV with reporting category DA, DB, DC or DD, this non-reportable event name is displayed in J2.11.



Steps:
1. The case has several events.
For example, one of the events (shock/ショック) is checked on the "Do not include in the report" flag in the event tab.



2. In Analysis > PMDA info tab, set the reporting category DA, DB, DC or DD to Japan INV license

3. Enter mandatory value for PMDA E2B R3 INV
4. Save the case
5. Schedule PMDA E2B against the license with reporting category DA, DB, DC or DD
6. Review PMDA E2B

The non-reportable event (shock/ショック) which has "Do not include in the report(報告対象に含まない)" flag is populated in J2.11.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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