Last updated on APRIL 15, 2011
Applies to:Adverse Event Reporting System - Version: 4.5.1
Information in this document applies to any platform.
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'.
- Create a new case or open existing case.
- Reporters - Source Type = SPONSORED STUDY.
- Reporters - Country = FRANCE.
- From the Case Details screen - Country where event occurred = UNITED STATES.
- Save the case.
- Run an E2B Report for this case.
- Confirm that <primarysourcecountry> is populated with 'FR' (For France).
- Confirm that <occurcountry> is populated with 'US' (For United States).
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