Auto-Submissions | Vault Help

Learn how to submit and distribute multiple files directly from a case using the Auto-Submit field.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Auto-Submissions

With auto-submissions, Vault Safety can submit multiple ICSR files to the gateway destination directly from the Case. Once reporting obligations are evaluated for a Case, users can submit at the Case level without having to navigate to each Submission or Distribution.

Key Concepts

Distribution: An Individual Case Study Report (ICSR) that is transmitted to an organization other than a health authority.
Submission: An ICSR that is sent to a health authority.
Transmission: Both Submission and Distribution records.
Schema Validation: An E2B file validation based on the file type and the XML Schema defined by the Agency (e.g. FDA E2B R2, EMA E2B R3).

Use the Submit to Gateway Action from a Case

When configured, the Submit to Gateway action allows you to submit multiple Distributions and Submissions from a Case record. Your Vault may be configured to trigger this action when a Case is Approved.

You will not be able to trigger this action if:

The Validation Status is Hard Fail. Your Admin can configure the Result Status Type to Hard Fail for certain Validation Criteria to prevent Gateway Submissions.
Vault is in the process of evaluating reporting obligations for the Case.

Note: If you use Auto-Submissions to multiple destinations that are triggered automatically as part of a workflow, your Admin can configure the Async Submit to Gateway feature to improve the performance of your Vault when sending transmissions.

Note: If Strict Transmission Version Enforcement is enabled, Vault will not auto-submit Follow-up Submissions before the previous Submission to the same Destination and Transmission Profile (or Destination ID for the PMDA) is ACK Accepted or Completed.

The Transmission record is eligible for auto-submission if:

It is in the Active lifecycle state.
It has the Auto-Submit field set to Yes.
The Validation Status is not Fail or Hard Fail.
It is not currently in any In Progress or Complete lifecycle states.
- In Progress States:
  - Sending ICSR
  - Sending Attachments
  - MDN Received
  - E2B ACK Accepted
- Complete States:
  - Complete
  - Withdrawn
  - Inactive

Before submission to the Gateway, the Transmission files are regenerated and the schema is validated.

Note: If both the Submit to Gateway / Async Submit to Gateway and the Evaluate Submission Obligations actions are executed in close succession, the Auto-Submission document generation can sometimes complete before the initial document generation. If you are affected by this issue, please contact Veeva Services to determine if you need to enable the Suppress File Generation for Auto-Submit Transmissions setting.

Use the Auto-Submit Field

Auto-Submit is a field on the Transmission and Transmission Profile objects. You can use the Auto-Submit field to include or exclude Distribution and Submission Transmission records for auto-submission from a Case.

An administrator can configure the Auto-Submit field on the following types of Transmission Profiles:

AS2 Gateway
Email Profile
Partner Exchange Profile
System Gateway

When an Admin pre-configures the Auto-Submit value on a Transmission Profile, that value is copied to any transmissions generated using that profile. Vault overrides this value if the Reporting Rule that triggered the creation of the Transmission contains the Auto-Submit Override Reporting Rule Parameter. See the Reporting Rule Parameter Reference for more information on this parameter.

Note: You may override the Transmission Profile Auto-Submit value at the Transmission level.

Note: Regardless of the setting on the Transmission Profile, if the Cancel Auto-Submit for Translations feature is enabled, Vault prevents automatic submissions for unapproved Localized Cases.

Transmission E2B XML Files

Transmission XML files are regenerated before submission to capture the most accurate Transmission Date. At this time, the Transmission Date field on the Transmission record is also updated to reflect the value in the XML file.

When a Transmission record is created and Auto-Submit field is set to Yes, the Transmission Date field value will be set to the current date and time the record was generated. The field will be set again at the time the file is auto-submitted to the Gateway. This is to ensure the value is populated with the most accurate date/time stamp and that it doesn’t result in the schema Validation Error.

Note: These Auto-Submission default values can be overridden at the Transmission level.

The schema file is validated - if there are validation errors, and based on the configuration, the file is excluded from the submission.

Audit logs are created for each Transmission record. The recorded user in the audit trail is the user that started the action at the Case.

An email notification will be sent for each auto-submitted record.

Lifecycle State Changes after Schema Validation

When an E2B file is generated for a Transmission, Vault validates the file’s schema and sets the lifecycle states accordingly.

When there are no schema validation errors and the Auto-Submit field has a value (either “Yes” or “No”), Vault updates the Transmission record (for the Submission and Distribution object types):
- When the Transmission Profile Type is “AS2 Gateway”, “Connection”, or “System Gateway”, Vault sets the Transmission record to the Ready state unless your Admin has enabled the Suppress File Generation for Auto-Submit Transmission setting.
- When the Transmission Profile Type is “Email Profile”, Vault sets the Transmission record to the Ready state when:
  - The report is generated and blind protection is applied where required.
  - The cover letter is generated when specified.
When the Auto-Submit field is blank, The Transmission record is set to the Pending state.
If there are schema validation errors, the Transmission record is set to the Validation Error state and the Case record is set to Transmission Error.

If the Transmission file is not E2B format, the schema validation is skipped and the lifecycle states are set accordingly:

When the Auto-Submit field has a value (either “Yes” or “No”), the Transmission record (for the Submission and Distribution object types) is set to the Ready state.
When the Auto-Submit field is blank, the Transmission record is set to the Pending state.