10 Co-packaged Combination Product Case Processing

Use the following steps for creating/processing cases with Co-packaged Combination Products:

1. Book-in a Case with information received as per Source documents.
2. Enter the text of the second step here.
3. If the Suspect Product involved is a Combination Product, ensure the Primary mode of action (PMOA) product is selected first using product browser, and the vaccine data is entered.
4. Add the Constituent Device Product using Product browser.
5. Enter Device data in the Constituent Product.
6. Select Combination Product in the General > Case Classification field.
7. Save the case and ensure all the mandatory data required for the CBER submission is entered.
8. Perform Auto-scheduling and system schedules an eVAERS report for the PMOA Product to CBER_VAERS agency.
9. Click the Draft link to preview the report in the XML view.

   Note:

   The element <combinationproductreport> is populated with the true value indicating ICSR contains Combination Product.

   Note:

   The Device data is embedded within the <drug> block pertaining to the Primary mode of action product as in the example provided in the Single Entity Combination Product section.