Periodic Report Cases (PSUR) are Excluded in 8.x While Not Excluded in 7.0.5
(Doc ID 2468754.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.0 and laterInformation in this document applies to any platform.
Symptoms
Periodic Report cases are being excluded when processing the report in version 8.x of Argus while the same behavior is not observe in lower version of Argus (e.g 7.0.5).
Steps:
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1) Create a new case with Initial receipt and Central Receipt date of 05-Aug-2018 in both 7.0.5 and 8.1.2 (Ex cases: 7.0.5 - case: 18US16528 and 8.1.2 case: 2018US000000866)
2) Create a significant follow-up with date: 07-Aug-2018 and save
3) Create another significant follow-up with date: 09-Aug-2019; save and lock.
4) Scheduled a report to FDA
Create a PSUR template in both versions having the following specific details in place:
a) Report Date range: 07-AUG-2018 to 08-AUG-2018
b) "DLP version" selected
d) "Include Unlocked Cases" not selected
5) Observe that in 7.0.5, case: 18US16528 was reported while for 8.1.2, case: 2018US000000866 was not.
Cause
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In this Document
Symptoms |
Cause |
Solution |
References |