Sections in This Article
- About Auto-Submissions
- Use the Submit to Gateway Action from a Case
- Use the Auto-Submit Field
- Transmission E2B XML Files
- Lifecycle State Changes after Schema Validation
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.
- 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 system may be configured to trigger this action when a Case is Approved.
Note You will not be able to trigger this action if:
The Transmission record is eligible for auto-submission if the Transmission record:
- Is in the Active status
- Has the Auto-Submit field set to "Yes"
- The Validation Status is not Fail or Hard Fail.
- 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:
- In Progress States:
Before submission to the Gateway, the Transmission files are regenerated and the schema is validated.
Note If both the 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 feature.
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 administrator pre-configures the Auto-Submit value on a Transmission Profile, that value is copied to any transmissions generated using that profile.
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, the system 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:
- If there are no schema validation errors and the Auto-Submit field has a value (either “Yes” or “No”), the Transmission record (for submission and distribution object types) is set to the Ready state.
- The Transmission record is set to the Pending state if the Auto-Submit field is left blank.
- If there are schema validation errors, the Transmission record is set to the Validation Error state. Correspondingly, 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:
- The Transmission record (for submission and distribution object types) is set to the Ready state if the Auto-Submit field has a value (either “Yes” or “No”).
- The Transmission record is set to the Pending state if the Auto-Submit field does not have a value.