Learn how to configure your Vault to use Transmission Profiles for the FDA E2B(R3) format.
About the Feature
To support Transmissions to the FDA in FDA E2B(R3) format, Vault Safety introduces the following three (3) new Transmission Profiles:
- CDER Study: Used for study data Transmissions to the Center for Drug Evaluation and Research (CDER)
- CBER Study: Used for study data Transmissions to the Center for Biologics Evaluation and Research (CBER)
- CDER IND Exempt: Used for study data Transmissions for marketed products that are exempt from Investigational New Drugs (IND) requirements
Although the Transmission Profiles for FDA E2B(R3) Submissions and Distributions feature was released in 24R1, this article is published with 24R2 to support the release of the FDA E2B(R3) feature.
Related Feature Enablement
To support Device and Combination Product Cases reporting through the FDA E2B(R3) format, first ensure you have enabled the Update to Seriousness Picklist feature.
Additional Consideration
By default, the system uses global ICH E2B(R3) validations to evaluate FDA E2B(R3) reports. However, Vault Safety does not include FDA-specific validations for this format. We recommend that you configure custom Validation Criteria if you want to enforce FDA-specific business rules.
Activate the Transmission Profiles
The Transmission Profiles for FDA E2B(R3) exports are included in all Vaults, but are inactive. To make them active, complete the following steps:
- Go to Business Admin > Objects > Transmission Profiles.
- Select the Transmission Profile you want to activate.
- In the Object State dropdown, select Active.
- In the Change Object Status dialog, select Yes.