Safety Distribution: Overview

Safety Distribution Description

Sponsors and CROs are required to inform investigators of any Suspected Unexpected Serious Adverse Reactions (SUSAR) related to the Investigational Product. Safety Distribution provides a user-friendly place for sites to receive, review, and acknowledge safety documentation sent from a connected sponsor or CRO’s vault.

SiteVault Use

Using Safety Distribution, site staff can:

  • Receive safety documentation from sponsor or CRO vaults.
  • Review safety documentation from sponsor or CRO vaults.
  • Mark safety documents as Read.

Using Site Connect for Safety Distribution, sponsor and CRO teams can:

  • Send safety documentation to sites.
  • Receive read acknowledgements from sites.
  • Safety reports that are related to multiple studies are noted for review on every affected study.
  • Once a multi-study safety report has been marked as Read, all affected studies are updated.


SiteVault users with study access receive notifications when safety reports are received from a sponsor or CRO vault.

  • System sends every few hours.
  • Notifications are consolidated by sponsor or CRO.
  • Sponsor and CRO vault users receive notifications when safety reports are acknowledged in a SiteVault.

Documents: Available Tasks
Safety Notifications: Available Tasks
Knowledge Base
System Information
Site Tools