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Section H Is Empty On The MedWatch 3500A Device Report (Doc ID 1279053.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety - Version 5.1 and later
Information in this document applies to any platform.

Symptoms

From the Regulatory Reports tab, generating the MedWatch 3500A Device report form results in a report with no values entered in Section H.  

If the user generates a draft from the Medical Review (go to Case Actions --> Medical Review, select MedWatch 3500A Device and click on View Draft as seen below) they will see that Section H is populated.

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution


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