Vault Study Startup: Site Greenlight Process

This video demonstrates how Veeva Vault Study Startup streamlines the complex and highly regulated process of achieving site greenlight, enabling pharmaceutical and biotech companies to move study sites from selection to regulatory approval more quickly and compliantly. The core functionality centers on the use of milestones, which serve as structured checkpoints to ensure the diligent collection, review, and approval of all necessary documentation before a site can begin clinical activities.

The demonstration focuses on a specific Green Light milestone for a study site (e.g., US-105). Within the Vault system, these milestones track essential data, including planned and actual completion dates. Crucially, milestones can be configured with dependencies, meaning they cannot be completed until specific prerequisite documents are finalized and approved. The system allows for the definition of criteria that, when met, can trigger the milestone to automatically complete, enhancing efficiency and reducing manual oversight. Once the necessary criteria are satisfied, a workflow action is initiated to send the milestone for internal review, marking the transition from a "planned" status to "in internal review."

Workflow automation is a key feature highlighted in the review process. When the review workflow is initiated, the system automatically assigns designated reviewers, sets a due date, and sends an email notification. This notification includes a direct link that takes the reviewer immediately into the target milestone within Vault. The reviewer’s task is to verify that all required content is complete and ready to proceed. Vault provides an intuitive interface for this verification, presenting the set of required documents as selectable thumbnails on the right side of the screen. As each thumbnail is selected, the document's content detail is displayed on the left, allowing for a focused and efficient review. If any issues are identified during this process, they can be logged directly within the system.

Upon completing the content review, the reviewer navigates back to the milestone to finalize the Green Light Review task, indicating whether the review passed or failed. If the reviewer selects "failed," the system enforces compliance by requiring the user to enter a specific issue type and corresponding comments, ensuring a clear audit trail for non-compliance. The platform is highly configurable, allowing study managers to set up additional workflow steps, such as escalation and follow-up actions, to efficiently manage identified issues. Finally, study managers maintain comprehensive oversight of the entire process using integrated Vault reports and dashboards, such as the Site Green Light Status Report, which provides both tabular and graphical representations of green light progress across all sites in a study.

Key Takeaways: • Structured Milestone Management: The Green Light process is managed through defined milestones within Vault Study Startup, which track key dates (planned vs. actual) and ensure a structured, auditable progression from site selection to regulatory approval. • Dependency-Based Automation: Milestones can be configured with dependencies on specific documents, ensuring that regulatory prerequisites are met before the site can advance. The system supports auto-completion based on these criteria, minimizing manual intervention. • Automated Workflow Initiation: Initiating the internal review process triggers automated workflow actions, including assigning reviewers, setting due dates, and sending email notifications with direct links to the required documents and milestone. • Intuitive Content Review Interface: Vault facilitates rapid and compliant document verification by providing an intuitive interface where required content is displayed as selectable thumbnails, allowing reviewers to efficiently view content details and log issues. • Enforced Compliance and Audit Trails: If a review fails, the system mandates the entry of specific issue types and detailed comments, ensuring a clear, documented audit trail necessary for GxP and regulatory compliance. • Configurable Issue Management: The platform supports custom workflow steps, such as escalation and follow-up actions, which can be configured to efficiently address and resolve issues identified during the green light review process. • Real-Time Study Oversight: Study managers gain actionable insights into the status of all sites through integrated Vault reports and dashboards (e.g., Site Green Light Status Report), allowing for graphical tracking of progress and proactive management of bottlenecks. • Centralized Regulatory Control: By centralizing the collection, review, and approval of highly regulated documents within a validated Veeva environment, the system significantly reduces the risk of errors and non-compliance associated with manual tracking methods.

Tools/Resources Mentioned:

• Veeva Vault Study Startup
• Vault Reports and Dashboards

Key Concepts:

• Site Greenlight Process: The critical, highly regulated process in clinical trials where all necessary documentation (regulatory, ethical, contractual) must be collected, reviewed, and approved before a study site is authorized to begin enrolling patients.
• Milestones: Defined checkpoints within the Vault system used to track the progress of a study site through the startup process, often linked to specific document completion requirements.
• Dependencies: Conditions or prerequisite documents that must be completed or approved before a specific milestone can be advanced or completed.