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EMA R3 Data Element - FULFILLEXPEDITECRITERIAR3 (C.1.7) Populates As False In XML file (Doc ID 2643362.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 8.1.1 and later
Microsoft Windows (32-bit)

Symptoms

EMA R3 report is showing "False" for the data element FULFILLEXPEDITECRITERIAR3 (C.1.7) for all the cases. This behavior is observed when the report was auto-scheduled and generated by AG Service.
However, for manually scheduled EMA R3 Reports the C.1.7 data element value populates as True.

Steps to repeat:

  • Login to Argus Safety
  • Create a reporting rule in Argus Console to schedule EMA R3 Report.
  • Book-in a case and provide minimum case data in order to generate R3 Report.
  • Lock the case and let the AG Service schedule and generate the R3 report.
  • Once the report is generated, open the case and go to Regulatory Reports tab
  • Select the report -> Click Final link -> ICSR Viewer ->Select format -> Decoded View -> C.1.7 display as False
  • Now manually schedule the EMA R3 report for the case and for same agency
  • Generate the report manually -> ICSR Viewer -> Select Format -> Decoded View -> C.1.7 display as True

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution


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