Guidelines/Requirements

• Research Organization Administrator users can add users to one or more sites at a time when the research organization is selected in the vault selector.
• Site Administrators can only add users to their currently selected site.
• At the time of user creation or addition, a Monitor or External User must be assigned to at least one study.
• If a monitor does not want to reuse an existing Vault account, we recommend they self-register for VeevaID before you add them to your site.
• A notification is issued to the Monitor upon receiving access to a study.

For more access information, see About Roles and Permissions, or download the SiteVault Security Matrix or SiteVault User Access Guide.

Creating a Monitor or External User

Complete the following steps to create a new Monitor or External User or add an existing Vault Monitor or External user to SiteVault:

1. Access Administration > Monitors & External Users and select Create.
2. Enter the email address of the user to add, re-enter the email address, then select Check Email.
   • If a user with that email address already exists in your research organization, enter an email address unique to your research organization.
   • If one or more existing Vault user accounts are found, select the appropriate user account. Contact your Research Organization’s administrator or the individual if unsure.
   • If no Vault user accounts are found, then continue creating the user.
3. Complete the First Name and Last Name fields.
4. If applicable, complete any SiteVault Enterprise-specific fields:
   • User Account Login Method: Select the appropriate login method.
   • User Name: Enter a user name.
   • Federated ID: Enter the user’s Federated User ID.
5. Select Next.
6. Select the + Add Study button, select one or more studies, and select Save.
7. Optionally, complete the Scheduled Access Start and End Date fields.
8. Select Save.