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?