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Unable To Populate E2B Field A.2.2 For Study Reports With Literature Details (Doc ID 1907572.1)

Last updated on DECEMBER 05, 2019

Applies to:

Oracle Argus Safety - Version and later
Information in this document applies to any platform.


Oracle Argus Safety Version

Recently received an observation from the Danish Medicines Agency that the literature articles based on a study / non-interventional study need to be reported with the Report Type as Report from Study and not Spontaneous.

Currently for cases which received from regulatory authorities and business partners having literature details but reported as Study reports we are unable to capture literature details in field A.2.2, because the A.2.2 field gets populated only when we select the report type as “literature”.

This functionality is not in line with the regulations of EMA and the E2b field A.2.2 literature reference should always be enabled irrespective of any report type selected.

How can one address this requirement?


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