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Guidance Required For Event Patient Problem Codes IMDRF For EMDR (Doc ID 2976447.1)

Last updated on SEPTEMBER 26, 2023

Applies to:

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

Goal


Guidance required for Patient problem code (IMDRF) for the Electronic Medical Device Report (eMDR)

There is a field:  'Patient Problem - Health Effects - Clinical Signs and Symptoms or Conditions Code' in the events tab.

e.g.



1. Request confirmation on whether this should be event-specific and added to clinical events only.

Note: can add just one patient problem code per event. should this be one patient problem code per event?

2. Also, how is this code populated in the eMDR?


 

Solution

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In this Document
Goal
Solution


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