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.
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.
Sponsor Use in Clinical Vault
Using Site Connect for Safety Distribution, sponsor and CRO teams can:
- Send safety documentation to sites.
- Receive read acknowledgements from sites.
Safety Documentation Related to Multiple Studies
- 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.