Learn how to create users and manage their system roles and add-on permissions.
Viewing Users
You can view users for your site or research organization in the Administration tab, then selecting either Staff or Monitors & External Users. The list of users displayed will filter when you have a Site selected; to see Users across your research organization, select your Research Organization.
To view a single user’s information and study assignments (if available), select the user to open their User record.
Creating Users
When you create a new SiteVault user for your site, you can choose from a set of system roles and, if needed, additional add-on permissions. See the About System Roles and Add-on Permissions page to learn more about what levels of access these roles and permissions provide.
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.
Creating a Staff User
Complete the following steps to create a new Staff user or add an existing Vault Staff user to SiteVault:
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Navigate to the Administration > Staff tab and select Create. The Create Staff page is displayed.
- Enter the email address of the user you want to add, then select Check Email. SiteVault checks whether the email account is associated with an existing Veeva Vault user account.
- If a user account already exists, complete one of the following actions:
- Vault User Account Exists: A green checkmark is displayed if only one existing Vault user account is found. Continue to Step 6. (If you don’t want to add the user to your site using the existing user account, select Click Here and continue to Step 5.)
- Multiple Vault User Accounts Exist: SiteVault displays an orange exclamation point if multiple user accounts already exist along with the user accounts. Select the appropriate user account (contact the person if you’re unsure which user account to select). Continue to Step 6. (If you don’t want to add the user to your site using the existing user account, select Click Here and continue to Step 5.)
- If an account doesn’t already exist (or if you chose to add an existing user as a new user), enter the user’s first and last name and a unique user name.
- Select the appropriate option for whether the user is an investigator.
- In the System Access & Permissions section, select a system role for the research organization and the site as well as any optional add-on permissions.
- Select Save.
See the Adding a New Staff User training video for more information.
Creating a Monitor or External User
To add a Monitor or External User to SiteVault, the user must be assigned to at least one study at the time of the user creation/addition.
Complete the following steps to create a new Monitor or External User or add an existing Vault Monitor or External user to SiteVault:
- Navigate to the Administration > Monitors & External Users tab and select Create. The Create Monitor/External User page is displayed.
- Enter the email address of the user you want to add, then select Check Email. SiteVault checks whether the email account is associated with an existing Veeva Vault user account.
- If a user account already exists, complete one of the following actions:
- Vault User Account Exists: A green checkmark is displayed if only one existing Vault user account is found.
- To continue with the existing account, click Next.
- If you don’t want to add the user to your site using the existing user account, select the Click Here link.
- Multiple Vault User Accounts Exist: SiteVault displays an orange exclamation point if multiple user accounts exist.
- Select the appropriate user account (contact the person if you’re unsure which user account to select).
- If you don’t want to add the user to your site using one of the existing user accounts, select the Click Here link.
- If an account doesn’t already exist or if you chose to add an existing user as a new user, enter the user’s first and last name and a unique user name.
- On the Site Access and Study Assignment tab, select the appropriate site in the Site field.
- Click the Add Study button and select the appropriate studies to add to the Monitor or External User.
- (optional) Complete the Schedule Start and End Date fields. If left blank, the user will immediately have access to the study documents in SiteVault.
- Select Save.
See the Granting Monitor/External User Access training video for more information.
You can edit certain user details such as name, email address, and whether the user is an investigator (Staff records). You can’t update a user’s user name. To edit a user’s information, open the record for the user from the Administration > Staff or Monitors & External Users tabs and select Edit.
Adding a User to an Additional Site
Complete the following steps to add an existing SiteVault user in your research organization to an additional site or sites:
- For Site Administrator users, ensure that the site to which you want to add the user is selected in the vault selector.
- From the Administration > Staff or Monitors & External Users tab, open the record of the user that you want to add to the site.
- In the Access & Permissions section, select Edit User Permissions.
- Select a system role for the site and (if applicable) any optional add-on permissions.
- Select Save User Permissions.
Editing a User’s Research Organization-Level Permissions
Note Only Research Organization Administrators can edit a user’s research organization-level system role and add-on permissions. To edit a user’s site-level permissions, follow the steps in the next section.
Complete the following steps to edit a user’s permissions for your research organization:
- Ensure that your research organization is selected in the vault selector.
- From the Administration > Staff or Monitors & External Users tab, open the record of the user that you want to edit.
- In the Access & Permissions section, select Edit User Permissions.
- Update the user’s research organization system role and add-on permissions as needed.
- Select Save User Permissions.
Editing a User’s Site-Level Permissions
Complete the following steps to edit a user’s system role and add-on permissions for a site:
- For Site Administrator users, ensure that the applicable site is selected in the vault selector.
- From the Administration > Staff or Monitors & External Users tab, open the record of the user that you want to edit.
- In the Access & Permissions section, select Edit User Permissions.
- Update the user’s system role and add-on permissions for the site as needed.
- Select Save User Permissions.
Removing a User’s Access to a Site
Complete the following steps to remove a user’s access to a site:
- Ensure that the applicable site is selected in the vault selector.
- From the Administration > Staff or Monitors & External Users tab, open the record of the user that you want to edit.
- In the Access & Permissions section, select Edit User Permissions.
- Update the user’s system role for the site to No Access.
- Select Save User Permissions.
Deactivating a User for a Site
A user is automatically added to your site in an Active status when you create or add a user. If a user leaves your site and no longer needs to be active in the system, Research Organization Administrator users can fully deactivate the user. Complete the following steps to deactivate the user for the site:
- Ensure that all of the user’s study assignments (or, if applicable, monitor or auditor assignments) are in the Inactive status.
- From the Administration > Staff or Monitors & External Users tab, open the record of the user that you want to deactivate.
- Select Change State to Inactive from the Workflow Actions menu on the user’s record.
If you need to reactivate the user, complete the steps in the Creating Users section above.