Manage Research & Site Responsibilities

This video provides a focused tutorial on the administrative setup required for utilizing the Digital Delegation Log feature within Veeva SiteVault, Veeva's dedicated eRegulatory and electronic Investigator Site File (eISF) system for clinical research sites. The core objective is to instruct site administrators on how to create, manage, and define the standardized list of "responsibilities" that will later be assigned to study personnel, ensuring a compliant and organized approach to delegation of authority in clinical trials.

The process is strictly limited to users registered as Site Administrators, highlighting the critical nature of this administrative function for regulatory compliance. The administrator must navigate to the "Administration and Responsibilities" tab, where they manage both a pre-populated list of default responsibilities and the creation of custom, non-study-specific tasks applicable across the entire research organization. A key distinction emphasized is the separation between these organizational default responsibilities, which apply to all new studies, and the ability to later modify responsibilities specifically for an individual study without altering the site-wide defaults.

The tutorial walks through the mechanics of creating a new responsibility, which requires confirming three essential fields: the Name of the responsibility, its Category, and its Scope. The scope determines if the responsibility should be shared across all sites within the organization or applied only to a specific site. This feature supports centralized management for larger Site Management Organizations (SMOs) by allowing the site field to be left blank for organization-wide application. Once created, responsibilities can be managed using standard Vault actions, including editing via the pencil icon or deleting/copying via the action menu. The video concludes by noting that once these responsibilities are confirmed, the subsequent step is assigning them to specific users and studies, thereby activating the Digital Delegation Log functionality.

Key Takeaways: • Prerequisite for Digital Delegation: Establishing the organizational list of responsibilities is the mandatory first step for implementing and utilizing the Digital Delegation Log feature in Veeva SiteVault, which is essential for maintaining compliant records of personnel authority in clinical trials. • Role-Based Access Control: Only users designated as Site Administrators have the necessary permissions to access and modify the foundational responsibility settings within the "Administration and Responsibilities" tab, reinforcing the need for controlled access to critical compliance data. • Standardization vs. Customization: SiteVault facilitates standardization by allowing the creation of non-study-specific responsibilities that serve as default templates for all new studies, while simultaneously permitting study-specific modifications to accommodate unique protocol requirements without affecting the organizational defaults. • Centralized Management Feature: The platform supports large, multi-site organizations by allowing administrators to define responsibilities that are shared across all affiliated sites simply by leaving the site field blank during the creation process, promoting consistency across the research network. • Required Data Fields: When defining a new responsibility, administrators must accurately input the Name, assign a Category, and define the Scope (site-specific or organization-wide) to ensure the task is correctly classified and available for delegation across the appropriate studies. • Dynamic Maintenance: Responsibilities are not static; administrators are shown how to manage and edit existing entries using the standard Vault interface tools, including the pencil icon for editing details and the action menu for actions like deletion or copying to accelerate setup. • Regulatory Context (eISF): The accurate definition and subsequent delegation of these responsibilities form a core component of the electronic Investigator Site File (eISF), serving as the auditable record required by regulatory bodies (like the FDA) to verify that qualified personnel are performing GxP tasks. • Workflow Sequence: The video covers the initial setup phase; the defined responsibilities must then be actively assigned to specific users and integrated into the study's delegation log to become operational, completing the digital delegation workflow.

Tools/Resources Mentioned:

• Veeva SiteVault: The specific eRegulatory/eISF platform being configured.
• Digital Delegation Log: The feature that utilizes the defined responsibilities for compliant task assignment.
• Vault Selector: The tool used to ensure the administrator is operating within the correct organizational or site context before making changes.

Key Concepts:

• eRegulatory / eISF: The system for managing electronic regulatory documents and essential trial records at the site level, where the delegation log resides.
• Digital Delegation: The electronic process of formally assigning specific study tasks and authorities to qualified personnel, replacing traditional paper logs for enhanced compliance and audit readiness.
• Site Administrator: The user role responsible for high-level site configuration and maintenance of default organizational settings within SiteVault.