The NDA Report 15 Day Submission Cases (expedited Report), Displays The SOC Event Count Incorrect.
Last updated on MAY 10, 2017
Applies to:Oracle Argus Safety - Version 6.0.7 and later
Information in this document applies to any platform.
The NDA report 15 day submission cases (expedited report cases), displays the SOC tabulation event counts of expedited cases incorrectly.
Steps To Reproduce:
1. Other site created new case "DSE-2014-######" case owned by Europe site.
2. The case was routed from Triage to Finalization state and click on Auto Scheduling, Case contains US license for which labeling needs to be done from US site user through local labeling. Labeling for US license for serious event "XYZ" is UNKNOWN
3. FDA expedited report is generated, and entry is made in RPT_EXP_INCL_EVENT table for same.
4. Case routed to distribution and locked state, and entry is made in RPT_EXP_INCL_EVENT table for event XYZ/case revision/ listedness for US license as Unlisted.
5. US site user changes for same case and the US license labeling from Local Labeling screen for event "XYZ" from Unknown to Listed.
6. Even after change the labeling from Unknown to listed, the entry in RPT_EXP_INCL_EVENT table for event XYZ still holds event listedness as Unlisted and it's not changed to Listed.
7. When the NDA report is generated it displays incorrect SOC tabulation event count.
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