To support ICSR transmissions to the FDA in FDA FAERS E2B(R3) format, Safety introduces the following 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 the FDA FAERS E2B(R3) Submissions and Distributions feature was released in 24R1, this article is published with 24R2 to support the release of the FDA FAERS E2B(R3) feature.
26R1 Update: FDA FAERS E2B(R3): Primary Study Selection for Cross Reporting
With the 26R1 release, you can designate a primary Study Registration for Studies in their Library. This is useful when exporting cross-reported studies to FDA FAERS E2B(R3) files to ensure that Vault populates the correct Study Registration Number in the FDA.C.5.5a data element. After configuring this feature, see Manage Studies and E2B Generation: FDA FAERS E2B(R3) Mapping for more information.
Related Feature Enablement
To support device and combination product Cases reporting through the FDA FAERS E2B(R3) format, ensure you have enabled the Update to Seriousness Picklist feature.
Additional Consideration
Vault uses global ICH E2B(R3) validations to evaluate FDA FAERS E2B(R3) files. However, 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
All Vaults include the Transmission Profiles for FDA FAERS E2B(R3) exports, but they are inactive. To activate them:
- Navigate to Business Admin > Objects > Transmission Profiles.
- Select the Transmission Profile you want to activate.
- In the Object State drop-down, 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 1 | FDA Center | Submission Type |
|---|---|---|---|---|---|
| CBER | Enter ZZFDATST |
Enter CDER |
Enter FDA_AERS |
CBER | AERS |
| CBER Study | Enter ZZFDATST_PREMKT |
Enter CBER_IND |
Enter FDA_AERS_PREMKT_ CBER |
CBER | AERS_PREMKT_CBER |
| CDER | Enter ZZFDATST |
Enter CDER |
Enter FDA_AERS |
CDER | AERS |
| CDER Study | Enter ZZFDATST_PREMKT |
Enter CDER_IND |
Enter FDA_AERS_PREMKT_ CDER |
CDER | AERS_PREMKT_CDER |
| CDER IND Exempt | Enter ZZFDATST_PREMKT |
Enter CDER_IND_EXEMPT_BA_BE |
Enter FDA_AERS_PREMKT_ CDER |
CDER | AERS_PREMKT_CDER |
| 1. Enter the Routing ID Field value exactly as shown, which for some Transmission Profiles (CBER Study, CDER Study, and CBER IND Exempt) contains a space. | |||||
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:
| Transmission Profile | FDA Batch Receiver Identifier Field | FDA Message Receiver Identifier Field | Routing ID Field 1 | FDA Center | Submission Type |
|---|---|---|---|---|---|
| CBER | Enter ZZFDA |
Enter CDER |
Enter FDA_AERS |
CBER | AERS |
| CBER Study | Enter ZZFDA_PREMKT |
Enter CBER_IND |
Enter FDA_AERS_PREMKT_ CBER |
CBER | AERS_PREMKT_CBER |
| CDER | Enter ZZFDA |
Enter CDER |
Enter FDA_AERS |
CDER | AERS |
| CDER Study | Enter ZZFDA_PREMKT |
Enter CDER_IND |
Enter FDA_AERS_PREMKT_ CDER |
CDER | AERS_PREMKT_CDER |
| CDER IND Exempt | Enter ZZFDA_PREMKT |
Enter CDER_IND_EXEMPT_BA_BE |
Enter FDA_AERS_PREMKT_ CDER |
CDER | AERS_PREMKT_CDER |
| 1. Enter the Routing ID Field value exactly as shown, which for some Transmission Profiles (CBER Study, CDER Study, and CBER IND Exempt) contains a space. | |||||
(26R1) Configure FDA FAERS E2B(R3): Primary Study Selection for Cross Reporting
To configure your Vault for this feature, add the FDA Primary IND field to the applicable Study Registration object layouts.