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Repeating IMDRF Terms in CFG_FDA_IMDRF_CODES for D12 and D1107 (Doc ID 2995941.1)

Last updated on JANUARY 05, 2024

Applies to:

Oracle Life Sciences Argus Safety - Version 8.4 and later
Information in this document applies to any platform.

Goal

In Argus Safety 8.4 there are duplications of the values below:



 

Note that the 'TERM' is repeated twice e.g.

'Sabotage or Intentional MisuseSabotage or Intentional Misuse'
which should just be 'Sabotage or Intentional Misuse'

and

'Known Inherent Risk of DeviceKnown Inherent Risk of Device'
which should just be 'Known Inherent Risk of Device'

This duplication appears in Argus Safety 8.4 and 8.4.1 in the backend Table CFG_FDA_IMDRF_CODES.

This issue does not replicate in earlier code versions such as Argus Safety 8.2.2 i.e.

 

Solution

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In this Document
Goal
Solution
References


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