Listedness should be ‘Unknown’ not ‘Unlisted’ when Event Assessments columns det_listedness_id=3 and datasheet_id = 99999
(Doc ID 2814554.1)
Last updated on DECEMBER 04, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.2 and laterInformation in this document applies to any platform.
Symptoms
User sees a few event assessment records for a few cases where datasheet_id =99999 (Unknown) and det_listedness_id=3 (Unknown)
User has no product for which they added datasheet_id =99999 (Unknown). Though it is present in lm_datasheet table.
User is able to replicate it with E2B imports using both a Customer FDA profile and an OOB FDA profile.
In both case, after importing the xml file, the user can see that an un-coded event is added, leading to no datasheet/listedness details showing in front end.
In the backend, event assessment record (det_listedness_id=3, datasheet_id=99999) is added, and persists even after coding the event.
This did not happen prior to upgrading to Argus 8.2.2
WORKAROUNDS: NA
Replication Steps:
1) Create one Not Blinded study with two inv products
2) Import an XML for FDA R2 profile
3) Accept the XML and create a case
4) In Case form event tab encode the event for "bleeding"
5) Observe the issue in AS 8222
More detailed description:
This is a problem because customer uses this data for validation checks to identify records which are ‘Unknown.’ When DET_LISTEDNESS_ID = 3 this should mean ‘Unknown’. However, this has been changed to be displayed as ‘Unlisted’.
User expects that the rows with DATASHEET_ID = 99999 will have a soft delete (date added to the ‘Deleted’ column. This is not happening.
Listedness should be ‘Unknown’ not ‘Unlisted’
Cause
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In this Document
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Cause |
Solution |
References |