The following requirements apply to creating monitor or external users:

• 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.
• A Monitor or External User must be assigned to at least one study at the time of user creation or addition.

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 the Administration > Monitors & External Users tab.
2. Select the Create button.
3. Enter the email address of the user to add.
4. Re-enter the email address.
5. 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.
   • You may have the option to create a new account using the Override option when existing accounts are found. If your company policy is to use the override option in certain scenarios, follow the Override option system instructions by selecting the click here link.
   • If no Vault user accounts are found, then continue creating the user.
6. Complete the First Name and Last Name fields.
7. 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.
8. Select Next.
9. Select the + Add Study button.
10. Select one or more studies.
11. Select Save.
12. Optionally, complete the Scheduled Access Start and End Date fields.
13. Select Save.