Discrepancy In Population Of B.4.K.4 Data In Reports Auto-scheduled To FDA
(Doc ID 2785848.1)
Last updated on MARCH 05, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.2 and laterInformation 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 |