Send a Gateway Transmission

You can transmit individual case safety reports from Vault Safety to AS2 Gateway endpoints.

Sections in This Article

What is AS2 Gateway Communication

Vault Safety supports AS2 interchange to communicate with trading partners and regulatory authorities. AS2 is a secure electronic data transmission protocol between two trading partners (gateways) through the Internet. Vault Safety can direct E2B transmissions to regulatory agencies and custom AS2 gateways.

The following interactive graphic shows the steps that occur when Vault Safety sends an E2B transmission to a regulatory agency gateway or trading partner.

Hover over the numbers for more information

Note The above diagram shows the process for asynchronous AS2 transmissions, used for EMA E2B (R3) and FDA VAERS E2B (R3). For synchronous AS2 transmissions, used for FDA E2B (R2), the MDN (step 4) is returned to Vault Safety using the same HTTP connection as the initial transmission (step 3).

Send a Gateway Transmission

To complete the ICSR Gateway Transmission, review the Transmission record and attachments to verify they are correct, and then trigger the Submit to Gateway action.

Prerequisites

  • The Transmission must be created, either as a Submission or Distribution.
  • An Administrator must have configured the Gateway and Transmission Profile for the destination organization.
  • You must have permissions to manage Submissions and Distributions. Typically, this is reserved for the Distribution Manager role.

Submit to Gateway Action

Use the Submit to Gateway action to send Submissions and Distributions with a System Gateway or AS2 Gateway Transmission Profile.

Note If the Validation Status for the Submission is Hard Fail, the Submit to Gateway action will not run. An administrator can configure the Result Status Type to Hard Fail for certain Validation Criteria.

When you trigger the Submit to Gateway action, the system automatically regenerates the E2B Transmission Document, assigns an E2B Message ID, and updates the Transmission Date field.

Depending on your vault’s configuration, this action may be available as a user action on Transmissions or triggered automatically as part of a workflow.

The system sends the submission to the destination Gateway configured in the corresponding Transmission Profile. Once complete, a notification appears on the Home tab under Notifications with the status of the submission.

Review the Transmission Document

  1. Go to the Transmission.
    Find Transmissions under the relevant Case or from the Transmissions tab.
  2. Beside File select the file link.
    The document appears in a new page.
  3. From the download-doc menu, select Source Document.
    The system downloads the .xml file.
  4. When the download is complete, open the file to review the ICSR.

Regenerate the Transmission Document

If the Case or Transmission changes, regenerate the transmission document.

  1. Go to the Transmission.
    Find Transmissions under the relevant Case or from the Transmissions tab.
  2. Expand the All Actions (All Actions) menu, and then select Generate Transmission Document(s).

Result

The system generates a new version of the document and updates the File field.

Types of Gateway Responses (ACKs and MDNs)

Every gateway transmission returns responses which indicate the success or failure of the transmission. These responses can be a Message Delivery Notification (MDN) or an Acknowledgment (ACK).

When a Vault Safety gateway transmission is sent, MDN and ACKs from the trading partner are added as Transmission Messages referenced by the outbound Transmission (Submission or Distribution).

Tip The following articles provide more information on inbound ACKs and MDNs:

See Gateway Transmission Workflow for more information on the standard Transmission lifecycle states.

Transmission Lifecycle States for Gateway Transmissions

Note This page describes the standard Transmission lifecycle states. If your organization has a custom lifecycle state configuration, follow the recommendations in your business standard operating procedures.

Lifecycle Stage Group Lifecycle State Description
Pending Ready Ready is the initial stage and state of a Transmission for which the Auto-Submit field was set to a value. Auto-Submissions provides more information.
Pending Pending Pending is the initial stage and state of a Transmission for which the Auto-Submit field was not set to a value. The system assigns a task to review and approve the Transmission and ICSR E2B file.
Pending Validation Error Vault Safety found errors during the E2B XML validation process.
Pending Ready for Submission The transmission and transmission document have been reviewed and approved, and the system has queued the transmission for sending to the destination gateway.
Sending Sending ICSR The transmission has been sent but the destination gateway has not sent an acknowledgment message yet.
Sent Sending Attachments Vault Safety is receiving an acknowledgment message from the destination gateway.
Sent Error Vault Safety could not send the transmission.
Sent MDN Received The transmission was acknowledged by the destination gateway.
Sent MDN Failure The transmission could not be delivered to, or acknowledged by, the destination gateway.
Sent E2B ACK Warning Vault Safety received the final ACK message indicating the destination gateway could not load the transmission.
Sent E2B ACK Rejected Vault Safety received the final ACK message with an error indicating the destination gateway loaded the transmission but rejected it, likely due to an issue in the E2B file.
Accepted E2B ACK Accepted The system received the final ACK message indicating the destination gateway accepted the E2B file and the transmission is complete. Note that the final ACK may still contain data warnings in this state.

Send an Email Transmission
Troubleshoot FDA Gateway Submissions
Feedback?