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 laterInformation 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 |