Enable Transmission Profiles for FDA E2B(R3) Submissions and Distributions

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.

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.

Configure Submissions

To configure test submissions for sandbox or validation Vaults and submissions for production Vaults, add the FDA Batch Receiver Identifier and FDA Message Receiver Identifier fields to all applicable Transmission Profile object layouts based on your business process.

Configure Transmission Profiles for Test Submissions

To configure test submissions in sandbox or validation Vaults, update the following Transmission Profiles and fields:

Transmission Profile	FDA Batch Receiver Identifier Field	FDA Message Receiver Identifier Field	Routing ID Field
CBER	Enter `ZZFDATST`.	Enter `CBER`.	Enter `FDA_AERS`.
CBER Study	Enter `ZZFDATST_PREMKT`.	Enter `CBER_IND`.	Enter `FDA_AERS_PREMKT_CBER`.
CDER	Enter `ZZFDATST`.	Enter `CDER`.	Enter `FDA_AERS`.
CDER Study	Enter `ZZFDATST_PREMKT`.	Enter `CDER_IND`.	Enter `FDA_AERS_PREMKT_CDER`.
CDER IND Exempt	Enter `ZZFDATST_PREMKT`.	Enter `CDER_IND_EXEMPT_BA_BE`.	Enter `FDA_AERS_PREMKT_CDER`.

Configure Transmission Profiles for Submissions

To configure submissions in production Vaults, you can leave the FDA Batch Receiver Identifier and FDA Message Receiver Identifier fields blank or update the following Transmission Profiles and fields: