Section G: Contact Office (and Manufacturing Site For Devices) Name And Address Information Missing In MedWatch Drug Form (Doc ID 2289027.1)

Last updated on JULY 27, 2017

Applies to:

Oracle Argus Safety - Version 8.0 and later
Information in this document applies to any platform.

Goal

Why is the following behavior observed:

Name and Address information in Section G "Contact Office (and Manufacturing Site for Devices)" of the MedWatch Drug report is missing when Comparator Drug is selected.

When the "Blinding Status" is set to "Broken By Sponsor" and the Study Drug selected is a Comparator Drug (coded from WHO Drug Dictionary in Study Configuration) in the Product section of the case form, the Name and Address information of the Manufacturer are missing on the MedWatch Drug form

The issue can be reproduced at will with the following steps.

  1. Create Double Blind case:
  2. Confirm Agency has "Allow WHO Drug reporting" checked under Agency Information tab
  3. Confirm Agency has an address is entered under Local Company Contact tab
  4. Save and Lock case
  5. Schedule New Report > MedWatch Drug report for case
  6. Section G. ALL MANUFACTURERS > Name and Address fields are populated
  7. Unlock case
  8. General tab
  9. Change Blinding Status to: Broken By Sponsor
  10. Products tab
  11. Select Study Drug that is Comparator
  12. Save and Lock Case
  13. Schedule New Report > MedWatch Drug report for case
  14. Section G. ALL MANUFACTURERS > Name and Address fields are NO LONGER populated

Solution

Sign In with your My Oracle Support account

Don't have a My Oracle Support account? Click to get started

My Oracle Support provides customers with access to over a
Million Knowledge Articles and hundreds of Community platforms