FDA MedWatch 3500A Normal Related Questions
(Doc ID 2385100.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 7.0.2 and laterInformation in this document applies to any platform.
Goal
Question 1:
1. 7.0.3 TRM
FDA MedWatch 3500A Normal
Red Dot #33
Source:
case_product.DEVICE_CODE
case_product.DEVICE_TYPE.
Where are these found in Argus Database?
Where are these found In Argus UI?
Question 2:
Where are the LOVs for ‘Malfunction Type’ under ‘Device Information’ section configured in Argus?
Question 3:
Are the fields ‘Device Sub-component name’ and ‘Device Sub component lot #’ free text or LOV?
Console > Argus > Code Lists > Device Subcomponents
Products tab > Device sub-tab
Device Subcomponent Lot#
Question 4:
Table: case_medwatch_data
Field:
FDA_PAT_CD1
FDA_PAT_CD2
FDA_PAT_CD3
FDA_DEV_CD1
FDA_DEV_CD2
FDA_DEV_CD3
For MedWatch Block F10, how are the values populated?
From which fields in Argus UI?
Question 5:
Analysis tab > Medwatch sub-tab
Unable to enter FDA Codes
When trying to type any text values into the fields, system displays the message:
"The code you entered is not valid".
Seems like these are LOV fields.
Where are these LOV fields defined?
Solution
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In this Document
Goal |
Solution |
References |