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Discrepancy In Population Of B.4.K.4 Data In Reports Auto-scheduled To FDA (Doc ID 2785848.1)

Last updated on JUNE 28, 2021

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

When two company suspect products with Marketed license are selected in a case and the reports are scheduled to FDA,
data for B.4.k.4.1, B.4.k.4.2 and B.4.k.4.3 are populate for primary product in the case.
However, for the second product, only B.4.k.4.3 (drug authorization holder) value is getting populate.

Steps to reproduce:
1. Create a case form with two products with marketed license
2. Schedule report to FDA reporting agency
3. B.4.k.4.1 and B.4.k.4.2 are not populate for second product. Only B.4.k.4.3 is populate.



Cause

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In this Document
Symptoms
Cause
Solution
References


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