9 Single Entity Combination Product Case Processing
These are the steps for creating/processing cases with Single entity Combination Products:
Book-in a case with information received as per Source documents.
If the Suspect Product involved is a Combination Product, on selection of the Product from Product browser, the system enables Drug and Device tabs.
Enter Drug and Device data in the corresponding tabs.
Select Combination Product in the General > Case Classification field.
Save the case and ensure all the mandatory data is entered that is required for CDER submission.
Perform Auto-scheduling and system schedules an E2B report to CDER agency using
the profile selected in the reporting destination EDI tab.
Click the Draft link to preview the report in XML view.
For E2B(R2), the <combinationproductreport> element is populated with
value 1 indicating ICSR contains combination product.
For E2B(R3), the <combinationproductreport> element is
populated as True.
Note:
You can
generate either E2B(R2) or E2B(R3) report.
For E2B(R2), the <fulfillexpeditedcriteria> element is populated and for
E2B(R3), the <localcriteriareporttype> element is populated with one of the
following values indicating the type of report:
1 = 15-day
2 = Non-Expedited
4 = 5-day
5 = Malfunction (30-day)
The Device data is embedded within the <drug> block
pertaining to the Primary mode of action product.