Sections in This Article
About Vault Safety Transmissions
You can transmit Individual Case Safety Reports (ICSRs) through the Transmission object, either using Submissions or Distributions.
Vault Safety comes with preconfigured workflows that support tracking transmissions outside of Vault Safety or sending transmissions electronically or manually.
Manage Submissions and Distributions from the Transmissions tab.
Transmission Object Types
You can transmit ICSRs to trading partners or regulatory authorities using Submissions or Distributions.
Use Submissions to report ICSRs to regulatory authorities.
Vault Safety supports regulatory submissions to the FDA, EMA, PMDA, and custom agencies. An Admin must configure the Gateway for each agency.
Use Distributions to share ICSRs with non-regulatory authorities, such as a partner, site, or market authorization holder.
Vault Safety automatically generates Transmissions when the Evaluate Reporting Obligations action runs. This action can be triggered by users through a user action on the Case object, or triggered automatically as part of case processing workflow. You can also create Submissions and Distributions manually.
When the Evaluate Reporting Obligations action runs, the system checks if the Case requires reporting to agencies or other organizations. The Case must match a reporting rule and Transmission Profile for a reporting destination. The following diagram shows an overview of this process:
In standard Vault Safety configuration, the Evaluate Reporting Obligations action runs when a Case moves to the Approved state. You can also configure auto-submissions to run from the Case level.
Transmissions and Subsequent Evaluations
The Vault Safety Rules engine re-evaluates reporting obligations on all Case data modifications whenever the Evaluate Reporting Obligations action runs on a Case.
Introduced in the 23R2 release, the Logically Delete Non-Submittable Transmissions on Subsequent Evaluations ICSR setting prevents over-reporting of Cases without needing to manually remove or update Submission records.
To enable this feature in your Vault, contact your Admin.
Logically Delete Non-Submittable Transmissions on Subsequent Evaluations
If this feature is enabled in your Vault, the system performs the following when the Evaluate Reporting Obligations action is re-run on a Global Case or a Localized Case for a Localization with a blank Assessment Generation method:
- Creates Transmissions for any submittable reporting obligations that were not created by previous Rule Engine runs.
- Marks any previously-created Transmissions that are no longer submittable as “Deleted”.
- Updates the Due Dates on all submittable Transmissions.
- Adds a new version of any previously-created Transmission Creation Message, appending details of whether any of the Safety Rules passed or if all the Safety Rules failed.
Note This feature applies to Transmissions created by the Safety Rules Engine only. Manually created Transmissions and Transmissions that have already been sent are not updated.
If the Logically Delete Non-Submittable Transmissions on Subsequent Evaluations feature is not enabled in your Vault, the system generates any newly submittable Transmissions, but does not update any previously generated Transmissions:
- Any Transmissions that no longer meet reporting obligations must be deleted manually.
- The Due Dates on any existing Transmissions must be updated manually.
A Transmission uses the Transmission Method specified on the associated Transmission Profile.
Vault Safety supports the following Transmission Methods: