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

Last updated on DECEMBER 23, 2024

Applies to:

Goal

Oracle Life Sciences 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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