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AERS Patch Does Not Appear to Resolve Bug 5931159 (Doc ID 1313835.1)

Last updated on APRIL 15, 2011

Applies to:

Adverse Event Reporting System - Version: 4.5.1 and later   [Release: 4.5 and later ]
Information in this document applies to any platform.


REF: <>   Oracle Adverse Event Reporting System Release (<>) Release Notes

This has the below details:


In the E2B Report, the <primarysourcecountry> shows blank if the case has the Source Type of 'Sponsored Study'.

This is a regulatory compliance issue. Bfarm (German Regulatory Authority) is requiring that the new field value appears in the E2B report.

In the E2B Report, the <primarysourcecountry> is correctly populated if the case has the Source Type of 'Sponsored Study'.

Re-Test Steps
  1. Create a new case or open existing case.
  2. Reporters - Source Type = SPONSORED STUDY. 
  3. Reporters - Country = FRANCE. 
  4. From the Case Details screen - Country where event occurred = UNITED STATES. 
  5. Save the case. 
  6. Run an E2B Report for this case. 
  7. Confirm that <primarysourcecountry> is populated with 'FR' (For France). 
  8. Confirm that <occurcountry> is populated with 'US' (For United States).
  However after testing above, details in the subsequent the .xml file instead shows:



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