Monitor & External User Access

Learn how to grant a monitor or external user access to your site, studies, and documents.

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Note Only SiteVault users with the Site Administrator system role can complete the steps in this section.

There are times when external users such as monitors, CRAs, or auditors will require access to your SiteVault. We have created specific permissions to easily grant them access, but limit their view to the necessary study data.

Access Details

Once added to a study, the external user can view and complete monitoring on documents for the study that are in the approved or steady state. See the section below for more specifics on their access.

• Access Provides
  • Ability to view and annotate documents in the approved or steady state (major version documents such as 1.0 or 2.0).
  • Ability to start (monitoring) Review Workflows on documents.
• Access Does Not Provide
  • Visibility to any documents in the Draft state.
  • Ability to edit, upload, or delete documents.
  • Ability to download participant source documents.
  • Ability to view financial documents such as contracts or budgets.
  • Access to the Study Connect application.
• System Specifics
  • The Scheduled Access Start Date must be a future date.
  • If not completed, the Scheduled Start Date defaults to today and the user immediately has access to the study documents in SiteVault.

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Monitor & External User Access Tasks

Create a Monitor or External User

• 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. Navigate to the Administration > Monitors & External Users tab and select Create.
2. Enter the email address of the user to add.
3. Select Check Email.
4. Select your next step, based on one of the following verification results:
   • If a user with that email address already exists in your research organization, then enter an email address unique to your research organization.
   • If one or more existing Vault user accounts are found, then select the appropriate user account. Contact your Research Organization’s administrator or the individual if unsure.
     • Enterprise users may have the option to create a new account if the existing options do not fit their login method/security policy requirements.
   • If no Vault user accounts are found, then continue creating the user.
5. Enter the user’s first and last names.
6. 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.
7. Select Next.
8. On the Site Access and Study Assignment tab, select the appropriate site in the Site field (this is defaulted if you have a site selected in the vault selector).
9. Select Add Study then select the appropriate studies to add to the Monitor or External User.
10. Optionally, complete the Scheduled Access Start and End Date fields.
11. Select Save.

Add a Monitor or External User to an Additional Site

Complete the following steps to add an existing Monitor or External User to an additional Site in your Research Organization:

1. From the Administration > Monitors & External Users tab, open the record of the user you want to update.
2. In the Access & Permissions section, select +Add Site Access.
3. Choose a site to which the Monitor or External User needs access. Only those sites to which you have access and the Monitor or External User does not yet have access are displayed in the dropdown.
4. Select Add Study.
5. Select the appropriate study.
6. Select Save.
7. Optionally, complete the Scheduled Access Start and Scheduled Access End fields.
8. Select Save to complete the process.

Add a Monitor or External User to an Additional Study

Complete the following steps to add an existing Monitor or External User to an additional study:

1. From the Studies tab, open the study record.
2. Expand the Monitor & Auditor Assignment section.
3. Select Create.
4. Complete the Study Role field.
5. Select the appropriate user from the User field.
6. Update the Scheduled Access Start and Scheduled Access End fields, if needed.
7. Select Save to complete the process.

Update a Monitor or External User Scheduled Access Dates

While the affected fields may be accessed on other menu tabs, these are the recommended steps for this task:

1. From the Studies tab, open the study record.
2. Expand the Monitor & Auditor Assignments section.
3. Select the user record from the User Assigned column.
4. Select the Edit pencil.
5. Complete the Scheduled Access Start or Scheduled Access End fields.
6. Select Save to complete the process.

Update a Monitor or External User Study Assignment Status

Complete the following steps to update an existing Monitor or External User’s Study Assignment status:

From the Studies Tab

1. Open the study record.
2. Expand the Monitor & Auditor Assignments section.
3. Select the user record from the User Assigned column.
4. Select the Edit pencil.
5. Change the status using one of the following tools:
   • Lifecycle State button located next to the user’s name
   • Workflow Actions menu located in the upper-right corner (chevron button)
6. Select Save to complete the process.

From the Administration Tab

1. From the Administration > Monitors & External Users tab, open the user record.
2. Expand the Study Assignments section.
3. Locate the site and study.
4. Change the status using the Lifecycle State button in the Assignment Status column.

Remove Site and Study Access from a Monitor or External User

Complete the following steps to remove site and study access from a Monitor or External User:

1. From the Administration > Monitors & External Users tab, open the record of the user you want to update.
2. In the Access & Permissions section, select Edit.
3. Select Remove Access in the row of the appropriate site.
4. In the Access & Permissions section, select the Save.
5. Confirm your intent to delete the selected site and move all Study Assignments (for this user, at this site) to inactive by selecting Continue.

Inactivate a Monitor or External User and their Study Assignments

Users are in the Active state when created or added to your site. If a user leaves your site and no longer needs to be active in the system, Admins can fully inactivate the user and their Study Assignments.

Complete the following steps to inactivate a user and their Study Assignments:

1. From the Administration > Monitors & External Users tab, open the record of the user that you want to inactivate.
2. Select Change State to Inactive from the Actions menu on the user’s record.
3. Select Continue to confirm your intent. This process may take a few minutes to complete.

If you need to reactivate the user, complete the steps to Create a Monitor or External User.

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Managing Users, System Roles, and Add-on Permissions

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Related Help

• Overview of Documents
• Creating & Finalizing Documents
• Deleting Steady-State Documents
• Documents FAQs