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Amendment Date is not displayed with (A) Suffix at PMDA Info > Comments > Aware Date (Doc ID 2531478.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Cloud Service - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

When a case has Amendment Followup, on Case Form >> Analysis >> PMDA Infor tab, (A) suffix is not displayed for the Amendment date.
The same dates (Significant Follow-up and Amendment) are displayed by the same format and unable to distinguish.

Case Form >> Analysis >> PMDA Info >> Comments >> Aware Date --- No (A) suffix is displayed on the drop-down list.

 

1) Create a new case and enter data.
2) Schedule and generate PMDA R3 E2B report.
3) Transmit and submit PMDA R3 E2B report.
4) Unlock the case as Significant Follow-up.
5) Add Amendment Follow-up on Case Form >> General.
6) Go to Case Form >> Regulatory Reports.
Click [Schedule New Report] button.
On the Schedule New Report dialog, fill values necessary fields and
click and open the drop-down at Aware Date field.
---> 2 same dates exist on the list and one of the date has (A).
7) Go to Case Form >> Analysis >> PMDA Info >> Comments.
Click and open the drop-down at Aware Date field.
---> 2 same dates exist on the list and none of the dates have (A).

 

 

 

Cause

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In this Document
Symptoms
Cause
Solution
References


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