PSUR Report: Listedness In The Report Not Matching With The Datasheet Listedness In The Case
(Doc ID 1492824.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 6.0.5.1 and laterInformation in this document applies to any platform.
Symptoms
PSUR Report: Listedness In The Report Not Matching With The Datasheet Listeness In The Case
The product used has 2 datasheets under the product - CORE-DS and SP-DS. There are two "licenses" under the CORE-DS and many licenses under the SP-DS.
The case is serious and for the event in question (Deep Vein Thrombosis), this event is listed in the CORE-DS datasheet and unlisted in the SP-DS.
The main line listing report of the PSUR report is showing the event "Deep Vein Thrombosis" as Unlisted when running the report using the CORE-DS datasheet in the inclusion criteria for each report type.
The event "Deep Vein Thrombosis" should be listed for the CORE-DS datasheet
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |