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 Sponsor or CRO’s Vault.

Site Connect Site User

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 acknowledgments from sites