Vault Safety supports exchanging individual case safety reports with trading partners, using AS2 Gateway or manually.
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.
Submissions
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 an AS2 Connection for each agency gateway.
Distributions
Use Distributions to share ICSRs with non-regulatory authorities, such as a partner, site, or market authorization holder.
Transmission Generation
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.
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, Vault 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:
When the Evaluate Reporting Obligations action runs, Vault snapshots any missing Study registrations from the Study library to the Case.
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, Vault 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.
Note: This feature does not apply to Localized Cases that contain a Localization with an Assessment Generation method of Case Product Registration. In such Cases, unused Submissions are moved to the Deleted state by the Generate Local Reporting Details action. For more information on Submission Generation and Linking for PMDA Localized Cases, see Report to the PMDA.
If the Logically Delete Non-Submittable Transmissions on Subsequent Evaluations feature is not enabled in your Vault, Vault 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.
Transmission Methods
A Transmission uses the Transmission Method specified on the associated Transmission Profile.
Vault Safety supports the following Transmission Methods:
