Getting Started

Basics for managing Study Connect for Site Staff and Site Administrators

Getting Started with Study Connect

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
1 Sign up for SiteVault
  1. Read this brief article that explains and links to the SiteVault sign-up process.
  2. Log in to SiteVault with the information included in your welcome email.

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.
  1. Log in to SiteVault.
  2. If you do not see Study Connect next to the SiteVault logo, select Switch to Study Connect (upper-right corner).
  3. Follow the instructions to locate and share the unique site identifier with your sponsor/CRO, enabling them to invite you to participate in the study through Study Connect.
  4. You have no additional steps to take until you accept the study invitation. While waiting for the invitation, you can watch training videos or set up your site.

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.
  1. Log in to SiteVault Study Connect and navigate to the Studies tab. Select the row with the study identifier that appears on the study invitation.
  2. Follow the instructions to accept the pending invitation.

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.
  1. Navigate to the Study Connect Site Staff tab.
  2. Review the Site Staff Overview.
  3. Follow the instructions to create your user accounts.

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.
  1. Navigate to the Studies tab, select the study.
  2. Follow the instructions to complete the requested tasks.

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.
  1. Navigate to the study’s Safety Distribution tab to review and acknowledge safety documents.