What is Study Connect?
Study Connect is an application within Veeva SiteVault that allows you to securely access and exchange trial information with sponsors/CROs using Veeva technology. See Study Connect: Overview for more information.
Using this Guide
Use this guide to set up your SiteVault and familiarize yourself with our Help articles and navigation. Simply click the links in each step, read and follow the instructions, then click back to this page for your next step.
Let’s get started!
# | Step | Description |
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1 | Sign up for SiteVault |
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2 | Provide Sponsor with Your SiteVault Identifier |
To connect their Veeva Vault with your SiteVault, your sponsor/CRO requires the unique site identifier Veeva assigned to your site.
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3 | Accept the Invitation to Connect |
When your sponsor/CRO has issued the study invitation, the study’s status on the Study tab will indicate that there is a pending invitation and your Site Administrators will receive an email notification. You own and control the data in your SiteVault; accepting the study invitation indicates that you grant permission to use SiteVault Study Connect to exchange study information with your sponsor/CRO.
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4 | Create Site Staff Accounts and Add Staff to Study |
You can create all your user accounts now or focus on the upcoming study team. New users will receive a welcome email with their login information and instructions to create a new password.
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5 | Complete the Regulatory Packet |
The Document Exchange tab provides a centralized place to access documents received from the sponsor/CRO and to complete document requests. The study status will indicate if document requests have been received. Site Administrators will also receive an email notification. The connected sponsor/CRO will receive a notification when tasks are completed.
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6 | Acknowledge Safety Distribution |
If your sponsor is utilizing Safety Distribution, you can easily review and acknowledge safety documents within Study Connect. Site Administrators will receive an email notification when a new safety document is available.
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