FDA E2B(R3) reports to capture verbatim drug reporting

Summary

Introduction of a new free text field for Verbatim Drug Reporting in Book-In and Case Forms to support FDA E2B(R3) compliance (Enhancement 20308352)

Description

According to the FDA Regional Implementation Guide for E2B(R3), Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2024 edition), the MEDICINALPRODUCT[G.k.2.2] data element must have the medicinal product name as reported by the primary source.

Book-In screen

During the book-in process, you can enter the verbatim product name in the Product Name as Reported field . This auto-populates the Product Name field, when you move to the next field (tab out). Once the Product Name field is filled, both the Product Name and Product Name as Reported fields can be edited and saved separately. After the product name is entered, either manually or automatically, you can continue to code the product using the existing functionality.

For sponsored trial cases, the Product Name as Reported field auto-populates with the study name based on the selected project/study ID, and then becomes read-only, similar to the Product Name field.

Case Form

The case form displays the Product Name as Reported as entered during initial book-in. If you add a new product directly in the case form, this field remains blank, allowing for free text entry.

In the blinded study cases, this field displays the study name in a read-only format. For open-label studies, it displays the configured drug name. When you add a new study drug, the Product Name as Reported field displays the study name as a read-only text.

Mapping updates

The Product Name as Reported value for products is transmitted in MEDICINALPRODUCT[G.k.2.2] for the FAERS E2B(R3) reports.

If the Product Name as Reported value is not available, then data entered in the Product Name field for products is transmitted as per the ICH guidelines.

For the unblinded studies, the product name used to break the blind for each study product is transmitted.

Note:

Post upgrade, the existing cases are unaffected as the Product Name as Reported field is optional.