Sections in This Article
- About Vault Safety Transmissions
- Transmission Object Types
- Transmission Generation
- Transmission Methods
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 the Gateway for each agency.
Distributions
Use Distributions to share ICSRs with non-regulatory authorities, such as a partner, site, or market authorization holder.
Transmission Generation
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.
Transmission Methods
A Transmission uses the Transmission Method specified on the associated Transmission Profile.
Vault Safety supports the following Transmission Methods:
