Vault eTMF Homepage Demo 1

This video provides an in-depth demonstration of the Vault eTMF (electronic Trial Master File) homepage, showcasing its utility as a centralized command center for TMF managers focused on maintaining inspection readiness. The core purpose of the dashboard is to visualize critical TMF metrics—timeliness, completeness, and quality—in real time, alongside actionable tasks and upcoming milestones. The interface is designed to provide an immediate, at-a-glance insight into the TMF's health, allowing managers to quickly assess team progress and prioritize the most crucial action items.

The dashboard’s structure facilitates focused oversight through a top-level study selector, enabling users to filter all displayed information—including tasks, metrics, and milestones—down to a specific study, country, or site. A key feature is the visualization of upcoming inspection readiness milestones. By hovering over these milestones, users can access detailed information, including the overall percentage completeness, any associated milestone dependencies, and a list of expected documents required for completion, allowing for proactive management and progression of trial phases.

The system provides granular metrics across the three pillars of TMF management. Completeness is quantified by displaying the number of unapproved documents and the overall percentage completeness relative to the expected document list and their required states. Timeliness is measured by tracking the percentage of documents approved within a configurable threshold, a crucial feature for ensuring adherence to internal SOPs and regulatory timelines. Quality management is addressed through a visualization of issues logged during the QC review process, allowing managers to track open versus closed quality issues and filter issues assigned specifically to them, thereby streamlining the resolution process.

Finally, the homepage integrates robust task management capabilities, separating tasks assigned directly to the user from tasks relevant to the entire study. The study-wide task view categorizes items into overdue, unassigned, and those due today. A significant utility of the homepage is its direct actionability; users can click into any widget or task listing to take immediate action or drill down into the details without navigating away from the central dashboard, establishing the eTMF homepage as an efficient tool for continuous compliance and oversight in clinical operations.

Key Takeaways:

• Centralized Inspection Readiness View: The Vault eTMF homepage serves as a single source of truth, aggregating real-time data on timeliness, completeness, and quality, which are the three primary indicators of TMF inspection readiness required by regulatory bodies.
• Proactive Milestone Tracking: Managers can track upcoming inspection readiness milestones, gaining visibility into associated dependencies and expected documentation, enabling them to proactively allocate resources and address potential delays before they impact regulatory submission timelines.
• Configurable Timeliness Enforcement: The system allows organizations to define and monitor a configurable threshold for document approval times, ensuring that TMF documents are processed and approved promptly, which is essential for maintaining the contemporaneous nature of the TMF.
• Quality Control Issue Management: The dashboard provides clear visualization of quality issues logged during the QC review process, distinguishing between open and closed items. This functionality helps TMF managers quickly identify persistent quality problems or bottlenecks in the review workflow.
• Granular Data Filtering: The study selector feature enables TMF managers to filter all metrics and tasks down to the level of a specific study, country, or site, which is critical for managing large, global clinical trials and performing targeted audits.
• Completeness Based on Document State: Completeness is measured accurately against the percentage of expected documents that have reached their required approved state, rather than simply counting filed documents, providing a more mature assessment of TMF status.
• Direct Actionability on Tasks: The integrated task management system displays overdue, unassigned, and due tasks for the entire study, allowing managers to click directly into these widgets and take immediate action on the underlying items without leaving the homepage interface.
• Support for Regulatory Compliance: By focusing on the continuous monitoring of timeliness, completeness, and quality, the eTMF homepage directly supports the GxP requirement for maintaining an accurate, complete, and readily accessible Trial Master File for audit purposes.

Tools/Resources Mentioned:

• Veeva Vault eTMF (electronic Trial Master File)

Key Concepts:

• Trial Master File (TMF): The collection of essential documents that permit the reconstruction and evaluation of the conduct of a clinical trial and the quality of the data produced, mandated by regulatory guidelines.
• Inspection Readiness: The continuous state of having a TMF that is complete, accurate, and organized enough to withstand a regulatory audit or inspection (e.g., by the FDA or EMA) at any time.
• Timeliness: A metric measuring the speed at which documents are filed and approved relative to the date of the activity they document, crucial for ensuring the TMF is contemporaneous.
• Quality Control (QC) Review: The systematic process of reviewing TMF documents for accuracy, adherence to protocol, and compliance with regulatory standards, with any deviations logged as quality issues.