Managing Multiple Sites using the Vault Selector

This instructional video provides a detailed guide on utilizing the Vault Selector feature within Veeva SiteVault Free, an eRegulatory and eISF (electronic Investigator Site File) system designed specifically for clinical research sites. The primary purpose of the Vault Selector is to enable users, particularly those with administrative access across multiple locations, to seamlessly navigate and manage data across different research sites or at the overarching research organization level. This functionality is crucial for maintaining operational efficiency, data segregation, and compliance within multi-site clinical trials managed by Contract Research Organizations (CROs) or large academic institutions.

The video clarifies that while the Vault Selector interface is visible to all users, only those granted access to multiple sites—such as Research Organization Administrators—can actually utilize it to switch contexts. The selector organizes the view hierarchically, listing individual sites beneath their corresponding research organization, which provides a clear structure for complex administrative oversight. The core function of the selector is to control the user's current working environment, determining which site's library, e-binder, and studies are visible and editable. This context switching is fundamental to the system's design, ensuring that all subsequent actions are correctly attributed to the intended location.

A critical emphasis is placed on the necessity of ensuring the correct site is selected at all times. The presenter issues a strong warning that failure to confirm the active site context can lead to significant compliance errors, such as uploading documents intended for one site into the records of another, or making unauthorized changes to the wrong study protocol. This highlights the feature's role as a gatekeeper for data integrity in a regulated environment, aligning directly with GxP requirements for accurate record-keeping.

Furthermore, the video explains navigation at the organizational level. By selecting the research organization rather than a specific site, administrators can access organization-wide profiles, such as partner organizations or products, providing a centralized view of shared resources. However, the presenter notes that certain site-specific operational actions, such as uploading new study documents or adding site-specific users, are intentionally restricted when viewing the organization level. To complete these tasks, the user must revert to selecting a specific site, reinforcing the system's design for granular control and adherence to documented site-level procedures.

Key Takeaways:

• Vault Selector is Essential for Multi-Site Management: The Vault Selector is the primary mechanism within Veeva SiteVault Free that allows Research Organization Administrators and other authorized users to efficiently manage and switch between the data environments of multiple clinical research sites.
• Regulatory Context Switching: The tool dictates the active site context, controlling which specific site library, e-binder (eISF), and studies the user is currently viewing and working within, which is vital for maintaining proper regulatory documentation segregation.
• Compliance Warning on Context: A critical operational best practice is to always verify the selected site in the Vault Selector before executing actions like document uploads or making changes, mitigating the risk of serious compliance violations such as cross-contaminating site documentation.
• Role-Based Access: Although the selector is visible to all, its functional use is limited to users with multi-site access permissions, ensuring that only authorized personnel can navigate and manage data across different organizational units.
• Organizational View for Centralized Governance: Selecting the research organization level provides administrators with a centralized view for managing shared resources, such as organization-wide partner organizations or products, streamlining governance across the entire research entity.
• Operational Restrictions at Organization Level: Veeva SiteVault enforces data integrity by disabling site-specific operational tasks (e.g., uploading new documents, adding site users) when the user is viewing the organization level, requiring the user to drill down to the specific site for execution.
• Hierarchical Structure for Clarity: The selector organizes sites logically beneath their parent research organization, which is beneficial for large CROs or sponsors managing complex portfolios of clinical trials and needing quick identification of the correct site context.
• User Profile Visibility: All users within a specific site are granted visibility to user profiles across their entire research organization, facilitating internal communication and collaboration among personnel involved in the same clinical research entity.

Tools/Resources Mentioned:

• Veeva SiteVault Free
• Vault Selector (Feature within SiteVault)
• eRegulatory / eISF system

Key Concepts:

• Veeva SiteVault: A specialized electronic system offered by Veeva for managing regulatory documentation (eRegulatory) and the electronic Investigator Site File (eISF) at clinical research sites, crucial for maintaining compliance in clinical operations.
• Vault Selector: A user interface element that controls the user's current working context within Veeva SiteVault, allowing navigation between individual research sites or the overarching research organization.
• Research Organization Administrator: A privileged user role responsible for overseeing and managing data and operations across multiple affiliated research sites within the Veeva ecosystem.
• e-Binder/eISF: The electronic binder containing all essential regulatory and study-specific documents for a clinical trial site; the Vault Selector ensures the user is interacting with the correct site’s eISF.