Vault eTMF Completeness

This video provides an in-depth exploration of how Veeva Vault eTMF supports the tracking and management of Trial Master File (TMF) completeness, emphasizing efficiency and accuracy in clinical operations. The demonstration begins by showcasing the TMF homepage within a clinical operations Vault, where users gain immediate oversight and visibility into critical TMF health metrics through intuitive graphs visualizing timeliness, completeness, and quality. The core focus is on the completeness aspects, illustrating how the system leverages milestones and Expected Document Lists (EDLs) to provide actionable insights and proactive management of the TMF throughout a study's lifecycle.

The presentation progresses by detailing the functionality of milestones, which are created from configurable templates within Vault. These milestones, when hovered over, reveal crucial information such as overall percentage completeness, dependencies, associated expected documents, and any related tasks. This templated approach ensures that as a study, country, or site is planned, the relevant milestones and EDLs are automatically released, guiding users to maintain TMF completeness from the outset. The video highlights how users can drill down into specific milestones to view key dates, dependencies, and a comprehensive list of all expected documents, which are fundamental for accurately reporting on TMF completeness.

A significant portion of the demonstration is dedicated to Expected Document Lists (EDLs), which serve as a dynamic checklist of documents expected (or not expected) for a specific study, country, site, person, organization, or product. The video illustrates how users can easily modify the "requiredness" status of documents from a template's starting basis or for those pending decision, as well as update the number of expected documents. Vault eTMF automatically calculates the number of final documents and the overall document count, providing a clear completeness status via intuitive icons. These icons—green circles for final completed documents, orange semicircles for in-progress documents, and red open circles for unfunded documents—offer a quick visual assessment of TMF health. The video concludes by demonstrating a streamlined drag-and-drop feature for filing documents, where metadata is largely pre-filled, and showcases Vault's robust reporting capabilities, allowing users to analyze TMF completeness at various levels, including the entire trial, individual sites, and different document types.

Key Takeaways:

• Centralized TMF Oversight: Veeva Vault eTMF provides a single, centralized view of key TMF health metrics, including timeliness, completeness, and quality, enabling clinical operations teams to maintain continuous oversight.
• Milestone-Driven Management: The system utilizes configurable milestones, generated from templates, to guide TMF planning and execution. These milestones provide detailed information on completeness, dependencies, and associated tasks, ensuring a structured approach.
• Dynamic Expected Document Lists (EDLs): EDLs serve as a critical checklist, defining documents expected or not expected for specific study contexts (e.g., study, country, site, person). They are dynamic and can be customized to reflect trial-specific requirements.
• Proactive Completeness Tracking: EDLs allow for the proactive planning and tracking of TMF completeness, moving beyond reactive checks by outlining what documents are needed at each stage of a trial.
• Visual Status Indicators: Intuitive completeness status icons (green for final, orange for in-progress, red for not filed) provide immediate visual feedback on the state of each expected document, facilitating quick identification of outstanding items.
• Streamlined Document Filing: The platform offers efficient document filing through a drag-and-drop interface. Metadata is largely pre-filled based on the expected document, significantly reducing manual data entry and potential errors.
• Robust Multi-Level Reporting: Veeva Vault eTMF provides powerful reporting capabilities that allow users to analyze TMF completeness at various granularities, including overall trial completeness, site-specific performance, and breakdown by document type.
• Ensuring Regulatory Readiness: By systematically tracking TMF completeness, the system helps organizations maintain a state of continuous regulatory readiness, crucial for audits and inspections by bodies like the FDA and EMA.
• Template-Based Consistency: The use of templates for milestones and EDLs ensures consistency across studies, countries, and sites, standardizing TMF setup and management processes.
• Actionable Insights: The combination of visual metrics, milestone tracking, and detailed EDLs provides actionable insights, allowing teams to quickly identify gaps and prioritize tasks to maintain TMF health.

Tools/Resources Mentioned:

• Veeva Vault eTMF
• TMF Homepage (within Clinical Operations Vault)
• Expected Documents List (EDL)

Key Concepts:

• TMF (Trial Master File): A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced.
• eTMF (electronic Trial Master File): A digital system for managing and storing the TMF, offering advantages in accessibility, searchability, and compliance.
• Milestones: Key events or stages in a clinical trial that trigger specific TMF documentation requirements and provide a framework for tracking progress.
• Expected Documents List (EDL): A configurable checklist within Veeva Vault eTMF that defines all documents anticipated for a specific study, country, site, or other context, serving as a guide for TMF completeness.
• Completeness Status Icons: Visual indicators (green, orange, red circles/semicircles) that quickly convey the filing status and finality of expected documents within the eTMF system.
• Metadata: Data that provides information about other data; in this context, descriptive information about documents (e.g., document type, study, site) that aids in organization and searchability.