Set up a Vault Safety FDA Gateway profile to support submissions through the FDA ESG.
Note: Vault Safety AS2 Connections are replacing Vault Safety Gateways. AS2 Connections provide significant technical improvements including Admin management of Internet Protocol (IP) lists, more concise outbound IP lists, and improved Certificate Management. Though Gateways are still supported, we recommend configuring your Vault to use an FDA AS2 Connection instead of the FDA Gateway.
About Vault Safety FDA Gateway Integration
Vault Safety supports the FDA Electronic Submissions Gateway (ESG) through AS2 (system-to-system) communication. Vault Safety supports CDER, CBER, and CBER VAERS electronic submissions to the FDA.
Vault’s integration with the FDA ESG allows you to set up a Gateway Profile for users to submit directly from Vault Safety and receive gateway responses.
Types of FDA Electronic Submission Endpoints
The following table outlines the different FDA ESG endpoints that Vault Safety supports and the details for each:
| Endpoint | Setup | Document Format |
|---|---|---|
| CDER (Drugs) |
|
FDA E2B(R2) or FDA E2B(R3) |
| CBER (Biologics) |
|
FDA E2B(R2) or FDA E2B(R3) |
| CBER VAERS (Vaccines) |
|
FDA VAERS E2B(R3) |
| CDER Study (Drugs) |
|
FDA E2B(R3) |
| CBER Study (Biologics) |
|
FDA E2B(R3) |
| CDER IND Exempt (Drugs) |
|
FDA E2B(R3) |
Configure an FDA ESG AS2 Account
Before you can configure the Vault Safety Gateway Profile, you must have an active FDA ESG AS2 account. The FDA Website provides instructions to set up an AS2 account.
As part of the registration process, you must send a public and private certificate pair to the FDA. If you need help generating these certificates, contact Veeva Services.
When you configure your FDA ESG account, ensure that AS2 URL exactly matches the Vault AS2 URL for your Vault.
Copy Your Vault AS2 URL
- Go to Admin > Settings > Gateway Profiles.
- Open the appropriate Gateway Profile.
- Under Vault AS2 URL, select Copy URL.
Note: Starting in Vault Safety 20R3, the Vault AS2 URL contains /inboundV2/. This change does not affect communication in gateways previously set up with /inbound/.
Configure Sender User
For Submissions to the FDA, you must enter full contact details for the Sender User. This user’s information will appear in generated forms and E2B files. The Sender User is assigned on Submission records in the Sender (User) field.
Managing Roles & Security in Vault Safety provides more information on setting up user contact details.
An Admin can configure an FDA ESG Transmission Profile to populate this field with a default Sender User on system generated transmissions based on the Transmission Profile.
Note: If your organization is a CRO making Submissions on behalf of clients, you must configure a separate Sender User for each sponsor. You can leave the Sender (User) field blank on the Transmission Profile so it can be populated based on your sharing settings.
Configure the Vault Safety Gateway Profile
Vault comes provisioned with an inactive standard profile for the US FDA ESG and US FDA CBER VAERS. In order for users to send Submissions to the FDA ESG, you must configure and activate the US FDA ESG Gateway Profile.
Open the Gateway Profile for Editing
- In the Admin area, go to the Settings tab.
- In the left pane, select Gateway Profiles.
- Open the appropriate Gateway Profile.
- Select Edit. The profile page is unlocked for editing.
Enter the Gateway Profile Information
- Under Details, in the Sponsor Email Address field, enter the Vault user email address to be used as a contact in gateway transmissions.
- Under AS2 Profile Configuration, complete the following fields:
- Vault AS2 URL: Enter the URL where the FDA sends acknowledgments and responses for submissions. The DNS configured in the FDA Gateway Account must exactly match the URL in this field.
- Sponsor Certificate: Select Choose, and then open the private encryption certificate. The private certificate is usually a PFX file.
- Sponsor Certificate Password: Enter the password for the sponsor certificate.
- Sponsor ID: Enter the ID registered with FDA Gateway, typically your FDA D-U-N-S number.
- Health Authority Certificate: Select Choose, and then open the public encryption certificate received from the FDA during account setup. The public certificate is usually a P7B file.
- Health Authority ID: Enter one of the following FDA identification codes:
- For a production account, enter
ZZFDA. - For a test account, enter
ZZFDATST.
- For a production account, enter
- Health Authority URL: Enter the destination FDA Gateway URL.
- Gateway User: Select the Vault Safety user whose name should appear in audit logs and gateway transactions.
- Select Save.
- To activate the profile, on the top-right corner, select Set Active.
Note: The Gateway User Required checkbox is automatically populated by the system and is informational only.
Result
The FDA Gateway Profile is active and available to use to submit case reports to the FDA.
Configure FDA Transmission Profiles
Vault Safety comes with standard, system-provided Transmission Profiles for FDA submissions. You must configure these Transmission Profiles as part of the FDA gateway setup.
The following table lists the system-provided FDA Transmission Profiles:
| Transmission Profile | Description | Corresponding Gateway | Routing ID |
|---|---|---|---|
| CBER | ICSR transmissions to the Center for Biologics Evaluation and Research (CBER) | US FDA ESG | FDA_AERS |
| CDER | ICSR transmissions to the Center for Drug Evaluation and Research (CDER) | US FDA ESG | FDA_AERS |
| GWTEST | Test transmissions to the FDA | US FDA ESG | GWTEST_CONNECTION |
| CBER VAERS | VAERS ICSR transmissions to the Center for Biologics Evaluation and Research (CBER) | US FDA ESG | CBER_VAERS |
| CBER Study | Study data transmissions to the Center for Biologics Evaluation and Research (CBER) | US FDA ESG | FDA_AERS_PREMKT_ CBER |
| CDER Study | Study data transmissions to the Center for Drug Evaluation and Research (CDER) | US FDA ESG | FDA_AERS_PREMKT_ CDER |
| CDER IND Exempt | Study data transmissions for marketed products that are exempt from Investigational New Drugs (IND) requirements | US FDA ESG | FDA_AERS_PREMKT_ CDER |
Manage Transmission Profiles provides instructions on setting up Transmission Profiles.
When setting up the Transmission Profiles, see the following guidance on setting the Origin and Destination IDs:
- Origin ID: Enter the ID registered with FDA ESG, typically your FDA D-U-N-S number.
- Destination ID: Enter one of the following destination IDs:
- For a production account, enter
ZZFDA. - For a test account, enter
ZZFDATST.
- For a production account, enter
Note: When editing the FDA Transmission Profiles, do not edit the Routing ID.
Once you set up the FDA Transmission Profiles, the system uses the appropriate Transmission Profile to generate Submissions based on your Vault’s FDA reporting rules.
Configure FDA Study Manual Transmissions
For manual study case report submissions to the FDA to be coordinated outside of Vault Safety, configure the FDA Study Transmission Profile.
Note: The FDA is entering a transition period and will be accepting both FDA MedWatch and FDA E2B(R3) formats. Follow your organization’s procedures for determining how to submit premarket Cases to the FDA. Previously, the FDA Transmission Profile was available to generate and manage manual Submissions for ICSRs in a clinical study using the FDA MedWatch 3500A form.
Manage Transmission Profiles provides instructions on setting up Transmission Profiles.