Monitoring

Monitoring tasks for site staff and monitors or CRAs

Create a Monitor or External User

Who can complete this task?
  • Administrators

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. Indicate if the user should have access to Restricted documents.
  9. Select Save.
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