Expedited Case Not Populating On A PADER Report
(Doc ID 2565476.1)
Last updated on DECEMBER 04, 2023
Applies to:
Oracle Life Sciences Argus Safety Cloud Service - Version 7.0 and laterInformation in this document applies to any platform.
Symptoms
User is working on a PADER report for a specific reporting period. One particular case with an initial receipt date within the specified report period does not populate on the previous PADER report. This case was initially an expedited 15-day report that was submitted to the FDA. The case was downgraded and was no longer an expedited report.
User tried adding to an existing advanced condition (AC) to pull the case into this report but this did not cause the case to be included. Next they tried the different inclusion options in the Line Listing sub tab in the NDA report template. None of these attempts could get any of these to populate on the report.
Cause
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In this Document
Symptoms |
Cause |
Solution |