Granting Monitor/External User Access

This video provides a detailed instructional guide on managing external user access within Veeva SiteVault, focusing specifically on granting, scheduling, and updating access for monitors, Clinical Research Associates (CRAs), and auditors. The process is critical for ensuring controlled access to sensitive clinical trial documentation, supporting remote monitoring activities, and maintaining compliance with regulatory standards regarding audit trails and data integrity. The tutorial differentiates between two primary scenarios: granting access to new external users who have never visited the site before, and assigning access to existing monitors who have previous engagement history.

For new external users, the process begins in the Administration section under "Monitors and External Users." The system requires entering the monitor's email, which triggers a check against existing Veeva ID accounts. If an account is not found, the monitor may need to self-register. Once the user is identified, the site administrator must explicitly add the relevant study or studies the monitor will be visiting. A crucial step involves populating the access start and end dates, which precisely define the window during which the external user can view and complete remote monitoring tasks on documents that are in an "approved" or "steady state." If a start date is omitted, the system defaults access to the current day; if an end date is omitted, access remains open indefinitely, a potential compliance risk.

The video also details the streamlined process for assigning monitors who have previously worked with the site. This can be managed directly from the specific study page under the "Monitors and Auditors" tab. Here, the administrator selects the appropriate role (monitor/auditor), finds the user in the list, and sets the access start and end dates. Throughout the tutorial, emphasis is placed on the "assignment status pill," a convenient feature that allows administrators to quickly toggle a monitor's access between "active" and "inactive." Changing the status to inactive immediately revokes access and removes scheduled dates, while reactivating a user defaults the start date to the current day, requiring manual adjustment of the end date if needed. This granular control over access duration is essential for maintaining strict security protocols and ensuring that external users only have access during their designated monitoring periods.

Key Takeaways: • Differentiated Access Procedures: The method for granting access depends on the monitor's history; new users require creation via the Administration panel, while existing monitors can be added directly via the specific study page's Monitors and Auditors tab. • Veeva ID Integration: External users must be associated with a valid Veeva ID account, requiring sites to confirm proper email addresses or prompt monitors to self-register if an account is not found during the initial check. • Granular Study Assignment: Access is granted on a study-by-study basis, ensuring that monitors only view documentation relevant to the specific clinical trials they are assigned to oversee, enhancing data security and regulatory compliance. • Mandatory Access Scheduling: Defining explicit access start and end dates is a best practice for controlled monitoring visits; omitting the start date defaults access to the current day, while omitting the end date leaves access open, necessitating careful management to avoid unauthorized prolonged access. • Document State Restriction: Monitors and external users can only perform remote monitoring activities on documents that are in the "approved" or "steady state," ensuring they are reviewing final, controlled versions of trial documentation. • Assignment Status Management: The "assignment status pill" provides a quick mechanism to revoke or restore access; setting the status to "inactive" immediately removes access and scheduled dates, which is crucial for rapid response during security or compliance events. • Reactivation Defaults: When an inactive monitor is toggled back to "active," the system defaults the access start date to the current day and clears the scheduled end date, requiring the administrator to manually re-enter the appropriate access window. • Updating Scheduled Dates: Scheduled access start and end dates can be easily updated via the action menu on the monitor study assignment page, allowing for flexibility in managing monitoring visit schedules without disrupting the user's account status. • Importance for Audit Trails: Precise control over access dates and statuses within Veeva SiteVault creates a clear, auditable record of who accessed the clinical data and when, which is fundamental for GxP and 21 CFR Part 11 compliance.

Tools/Resources Mentioned:

• Veeva SiteVault: The enterprise software platform used for managing clinical trial documents and site operations.
• Veeva ID: The identity management system used by Veeva to authenticate external users.
• Help Center/SiteVault Support: Resources for additional information and assistance.

Key Concepts:

• Monitor/CRA/Auditor: External users who require temporary, controlled access to site documentation for oversight and verification purposes during clinical trials.
• Assignment Status: A toggle (Active/Inactive) used to immediately control a monitor's ability to access assigned studies and documents.
• Scheduled Access Dates: The defined start and end dates that limit the external user's access window, crucial for maintaining security and compliance protocols.
• Approved/Steady State: The required status of documents within SiteVault for them to be visible and accessible for remote monitoring activities, ensuring only finalized, controlled documents are reviewed.