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Incorrect EU Codes For Causality Source - Pharmaceutical Company and Primary Source Reporter (Doc ID 2576663.1)

Last updated on AUGUST 20, 2019

Applies to:

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

Goal

Oracle Argus Safety Version 8.1.2.2 (upgraded from AS 7.0.5)

It was noted that EU codes for Pharmaceutical Company and Primary Source Reporter do not appear to be correct.

i.e.

Investigator has EU_CODE = 1 but Primary Source Reporter has EU_CODE = 2
Sponsor has EU_CODE = 2 but Pharmaceutical Company has EU_CODE =1

This shows up in below scenario:

Create a clinical trial case with different for Primary source reporter and pharmaceutical company
Create a clinical trial case with the same assessment as above but exchange primary source reporter with Investigator and pharmaceutical company with sponsor

compare the EU Assessment of the XML files for both cases


 

Solution

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In this Document
Goal
Solution
References


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