Table of Contents
- Title and Copyright Information
- Preface
- 1 Introduction
- 2 Configure Single Entity Combination Products
- 3 Configure Co-packaged Combination Products
- 4 Set up Reporting Destinations
- 5 Set up Reporting Rules
- 6 Configure Combination Product in Flexible Re-categorization Codelists
- 7 Single Entity Combination Product Case Processing
- 8 Co-packaged Combination Product Case Processing
- 9 Other Considerations
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10
FAQ
- What type of product configuration is recommended for Combination Products?
- In the flexible COMBO_PRODUCT_RELATI ONSHIP codelist, is it required to enter Product Name or Trade Name for PMOA and Constituent Products?
- Does the Combination Product solution provided byOracle Argus Safety allow configuration of Combination Product that comprises for multiple device constituents?
- For which type of Combination Products is the flexible codelist configuration required?
- If the Device is a PMOA Product, is it required to configure the combination products in the flexible codelist?
- Is MAH required to report cases that contain combination products that include a non-company product as PMOA?
- Do the entries populated in the CASE_PMOA_CONS_RELATI ON table for a case get copied on performing Case Copy?
- 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?
- If a PMOA Product has multiple device constituents associated, is it required to enter all the device constituents in the case in order to recognize the product as Combination Product?
- If a foreign case (Non-US) has a combination product having equivalent US licensed combination products, will the system be able to determine that the case qualifies for combination product reporting in US?