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 laterInformation 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
To view full details, sign in with your My Oracle Support account. |
|
Don't have a My Oracle Support account? Click to get started! |
In this Document
Symptoms |
Cause |
Solution |
References |