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

Last updated on MARCH 08, 2017

Applies to:

Oracle Argus Safety - Version 6.0.5.1 and later
Information in this document applies to any platform.

Goal

Oracle Argus Safety Version 6.0.5.1

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.

Please advise how can we address this requirement!
 

Solution

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