If a Case having drug and device data was submitted as eVAERS to FDA in prior versions of Oracle Argus Safety and now if there is a follow-up data is received and requires to be processed as Combination Product, what needs to be done from the data entry perspective?

Follow these steps to ensure the case is treated as Combination Product ICSR:

• Case Classification needs to be set to Combination Product.
• Ensure that the appropriate device information is entered for the device constituents.
• Generate the eVAERS report draft to the CBER_VAERS agency to check if case qualifies to be Combination Product Case.