Learn how to transmit 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, 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 ICSR Transmission.
Key Concepts
- ICSR Transmission: One of the ICSR Transmission types
- 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 ICSR Transmissions from a Case. 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 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- Withdrawn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
- 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 / 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, 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 type Transmission records for auto-submission from a Case.
Your Admin 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, Vault copies the value 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 Safety Rule Parameter.
Note: You may override the Auto-Submit value set by the Transmission Profile 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
Vault regenerates the transmission XML files before submission to capture the most accurate transmission date. Vault then updates the Transmission Date on the Transmission to reflect the value in the XML file. Vault updates this field value when the file is submitted to the gateway to reflect the most accurate date/time stamp and to ensure it does not result in a schema Validation Error.
When a Transmission is created and the Auto-Submit field is set to Yes, Vault sets the Transmission Date to the current date and time the record was generated.
Note: These auto-submission default values can be overridden at the Transmission level.
Vault validates the schema file. If there are validation errors, and based on the configuration, the file is excluded from the submission.
Audit logs are created for each Transmission. The recorded user in the audit trail is the user that started the action on the Case.
Vault sends an email notification 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, Vault skips the schema validation step and sets the lifecycle states as follows:
- When the Auto-Submit field has a value (either Yes or No), the ICSR Transmission is set to the Ready state.
- When the Auto-Submit field is blank, the ICSR Transmission is set to the Pending state.