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Monitors and clinical research associate (CRA) users can use SiteVault to perform remote monitoring of a research site’s regulatory and source documents for a study.
Click here to view a getting started checklist for monitors, and watch the following video to learn how to get started with SiteVault as a monitor or CRA:
To review a document:
- If you have been granted access to multiple sites or vaults, ensure that the appropriate site is selected from the Site Selector list in the upper-right corner of SiteVault.
- Navigate to Documents > Library, open the Ready for Monitor Review view, and select the document that you want to review. Alternatively, navigate to Reporting > Dashboards, open the Monitor’s Review Dashboard, then click the Documents Ready for Review widget to view the documents that are ready for review.
- Review the document. If applicable, click Annotate to annotate the document with any review feedback that requires the site’s attention.
- Once you are finished with your review, select one of the following options from the Action Menu:
- Passed Review With No Issues: Select this option if the document passed review with no issues, then click Start in the Mark as Review Complete, No Issues dialog box.
- Review Issues Found, Request Site Resolve: Select this option if you want to initiate a Resolve Review Issues task. Select the site staff member or members who you want to notify, then click Start. The selected site staff are notified to address your feedback. You will be notified (by email) when they complete the task.
- If a document that you have already reviewed as passed requires additional review at a later date, select Followup Review Issues Found, Request Site to Resolve from the Action Menu.
When a site mentions you in a comment or has completed a task to review your feedback on a document, you will receive an email notification.
To view your notifications, open the Notifications view in the Home tab.