Workaround for Bug 36638267 - Case Counts in Clinical Trial Periodic Report Summary Tabulation Do Not Match Listing
(Doc ID 3034467.1)
Last updated on JULY 23, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.3.2 to 8.2.3.2 [Release 8.2]Information in this document applies to any platform.
Goal
In the Clinical Trial Periodic Report (CTPR) > Cumulative Summary Tabulations section > Count of all events per study drug section, an event is counted once if the listedness is the same for multiple study products, but counted individually if the listedness is different for multiple study products present in the case.
Steps to replicate the issue:
1) Create a non blinded study (Study1) and include two study products: Product 1, Product 2
2) Create a case for this study and add both study products
3) Add 2 events: Event 1 and Event 2, both serious
4) In event assessment keep the assessment as below:
Event 1 – Product 1: Listed
Event 1 – Product 2: Unlisted
Event 2 - Product 1: Unlisted
Event 2 - Product 2: Unlisted
5) Generate the CTPR report for the study
6) The report has Count = 2 for Event 1, but Count = 1 for Event 2 in the "Count of all events per study drug" section
This is logged as Bug 36638267 Event in a Case counted more than once in CTPR summary tab when Count of all events are used which is targeted for fix in Argus 8.4.4.
Solution
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In this Document
Goal |
Solution |
References |