Completing Monitoring Visits as an External User

Watch the videos or follow the step-by-step instructions below to learn how to use SiteVault to perform monitoring of a research site’s regulatory and source documents for a study.


Finding Documents Ready for Review

Note If you have access to multiple sites or vaults, ensure that the appropriate site is selected in the vault selector.

Complete one of the following steps to find documents ready for monitor review:

  • Navigate to the Documents > Library tab, and select the Ready for Monitor Review view to view source documents that are ready for review. Note that profile documents are not displayed in this view because they’re non study-specific.
  • Navigate to the Documents > eBinder tab, and select the study in the Study Selector. Select the All Documents folder to view all finalized documents, or select a specific subfolder such as Staff > Qualifications (which contains the profile documents) to view a subset of documents.
  • Navigate to the Reporting > Dashboards tab and open the Monitor’s Review Dashboard. Select the Documents Ready for Review widget to view all documents that are ready for review.

Reviewing Documents

Complete the following steps to review a document:

  1. Review the document. If applicable, select View Annotations (View Annotations Icon) to annotate the document with any review feedback that requires the site’s attention.
  2. When you’re finished with your review, select one of the following options from the Workflow Actions menu:
    • Passed Review with No Issues: Select this option if the document passed with no issues.
    • Review Issues Found, Request Site to Resolve: Select this option if you’re requesting that the site resolve review issues. In the dialog box, select the site staff member or members who you want to notify and enter any optional task instructions. SiteVault sends the site staff a notification to address your feedback.
    • Followup Review Issues Found, Request Site to Resolve: Available on previously reviewed documents, select this option if you find additional issues that require the site to resolve. SiteVault sends the site staff member a notification to address your feedback.

Viewing Notifications

You’ll receive a notification by email and in SiteVault when a site staff member completes your request to resolve feedback. The notification includes the site staff member’s decision to either address your feedback by updating the document or by addressing your feedback without updating the document. You’ll also receive a notification if a site staff member mentions you in a comment.

Notification Bell Icon

To view your notifications, select the Notification Bell in the upper-right corner of SiteVault. You can select the View All link on the list to view all of your notifications on a single page along with any open tasks or annotation mentions.

Training and How-To Videos

Study eBinder & Document Library
Knowledge Base
System Information
Site Tools