About the Feature
With the 22R2 release, Vault Safety exported the Product (Reported) field, instead of the Product (Coded) field, by default on CIOMS I and FDA 3500A reports. This affected the following fields:
- CIOMS I:
- Section II, Field 14. Suspect Drug(s)
- FDA 3500A:
- Section C, Field 1.1 Name and Strength
- Section D, Field 1. Brand Name
Optionally, Admins could change the default export to the Product (Coded) field by contacting Veeva Support.
In 23R3, Admins can control whether the reported or coded Product is exported through an Admin Checkbox, Use Product(Reported) Name on CIOMS and MedWatch 3500A.
To view or change your setting, go to Admin > Settings > Submission and Distribution Settings.
By default, in your Vault’s Submission and Distribution Settings, this checkbox is selected. Clear the checkbox to use Product (Coded) by default instead of Product (Reported).
Note If Veeva Support previously set Product (Coded) as the default export in your Vault and you want to continue with that default, you do not need to take any action. In your Vault’s Submission and Distribution Settings, the Use Product(Reported) Name on CIOMS and MedWatch 3500A checkbox is automatically clear.
For more information, see the relevant sections in CIOMS I Generation Data Mapping and FDA 3500A Generation Data Mapping.
