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A.1.FDA.16 fdasafetyreporttype Only Shows Value of '3' (Postmarketing Safety Report) In Argus 8.2.3.1 - Why? (Doc ID 2915164.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Interchange - Version 8.2.3.1 and later
Information in this document applies to any platform.

Goal


fdasafetyreporttype is showing 3 in Argus 8.2.3.1

According to FDA requirements.
A.1.FDA.16


1=IND Safety Report
2=IND Exempt BA/BE Safety Report
3=Postmarketing Safety Report

But in Argus 8.2.3.1 it's showing as 3 for all cases. when generating the E2B R2 report for the Clinical trial case also it is showing as 3.
 

Solution

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In this Document
Goal
Solution
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