Vault eTMF Demo: Part 4 – TMF Viewer

This video provides an in-depth exploration of the Veeva Vault eTMF Viewer, a critical feature designed to streamline the management and navigation of Trial Master File (TMF) content within the Veeva Vault platform. The presenter begins by establishing the viewer's main purpose: enabling users to efficiently browse dynamically organized TMF content and switch between multiple configured hierarchies. This functionality is highlighted as particularly beneficial for supporting regulatory inspections, accommodating various inspector preferences for navigation, and significantly reducing the administrative burden traditionally associated with manual binder creation and maintenance. The core message is that Vault eTMF automates much of this work, allowing users to focus on content rather than organization.

The demonstration proceeds with a practical tour of the eTMF Viewer interface. Upon navigating to the TMF viewer tab, users are presented with a study, country, and site selector, a feature familiar from the TMF homepage launched in 19r1, which allows for granular drill-down into specific trial contexts. As selections are made (e.g., Finland and Site 5280), the folder structures on the left-hand side dynamically update to display only sections containing relevant content, a design choice directly influenced by customer feedback to avoid confusion from empty sections. The viewer also supports various TMF reference models, including versions 3.0, 2.0, and Veeva's proprietary "Vault Clinical Docs" hierarchy, offering flexibility in how documents are structured and viewed.

Further capabilities showcased include an "expand all" button for comprehensive viewing of all subsections and the ability to filter down to the contents of a single section. A key highlight is the robust search and filtering functionality. For instance, a study manager needing to identify expired investigator CVs can simply search for "CV" and then filter the expiration date column to pinpoint documents expiring before a specific date, a feature explicitly noted as valuable for inspections. The video also illustrates how to view different versions of informed consent forms (ICFs) by expanding search results. Crucially, the eTMF Viewer respects security and permissions, ensuring users only access documents they are authorized to see. The demonstration concludes by showing how users can perform direct actions on documents from within the viewer, such as logging quality issues or uploading new versions, and how to export lists of documents with hyperlinks that lead directly back to the content in Vault, further enhancing efficiency and accessibility.

Key Takeaways:

• Centralized TMF Management: The Veeva Vault eTMF Viewer provides a unified interface for managing and accessing all Trial Master File content, eliminating the need for disparate systems or manual binders.
• Dynamic Content Organization: The viewer dynamically organizes TMF content and allows users to switch between multiple configured hierarchies, such as the TMF Reference Model 3.0, 2.0, or Veeva's Vault Clinical Docs, offering flexibility in content presentation.
• Enhanced Inspection Readiness: The system is designed to support regulatory inspections by providing easy search, filter, and navigation capabilities, allowing inspectors to self-navigate or be guided through the TMF efficiently.
• Reduced Administrative Burden: By automating the organization and maintenance of TMF content, the eTMF Viewer significantly reduces the manual effort associated with binder creation and upkeep, freeing up valuable resources.
• Granular Navigation: Users can drill down to specific study, country, and site levels using a dedicated selector, ensuring focused access to relevant TMF documents for particular trial contexts.
• Intelligent Content Display: Based on customer feedback, the system intelligently displays only those TMF sections that contain actual content when specific study, country, or site filters are applied, preventing confusion from empty folders.
• Powerful Search and Filtering: The viewer offers robust search capabilities (e.g., searching for "CV" or "consent") combined with column filtering (e.g., filtering by expiration date) to quickly locate specific documents or identify items needing attention, such as expired investigator CVs.
• Version Control and Document Actions: Users can easily view different versions of documents, such as informed consent forms, and perform direct actions on documents from within the viewer, including logging quality issues or uploading new versions.
• Security and Permissions Enforcement: The eTMF Viewer strictly adheres to configured security settings and user permissions, ensuring that individuals can only access documents they are authorized to view, maintaining data integrity and compliance.
• Export Functionality with Direct Links: The ability to export lists of documents to Excel, with embedded hyperlinks that lead directly back to the respective documents in Vault, facilitates offline review and sharing while maintaining traceability.

Tools/Resources Mentioned:

• Veeva Vault eTMF
• TMF Reference Model 3.0
• TMF Reference Model 2.0
• Veeva's hierarchy: Vault Clinical Docs
• Microsoft Excel (for document list export)

Key Concepts:

• TMF Viewer: A specific feature within Veeva Vault eTMF designed for browsing, searching, filtering, and managing Trial Master File content.
• eTMF (Electronic Trial Master File): A digital system for managing essential documents of a clinical trial, crucial for demonstrating compliance with regulatory requirements.
• TMF Reference Model: An industry-standard, hierarchical model for organizing and categorizing TMF documents, ensuring consistency and completeness across clinical trials.
• Inspections: Regulatory audits conducted by authorities (e.g., FDA, EMA) to verify the conduct of clinical trials and the integrity of their documentation, for which an organized eTMF is critical.
• CV (Curriculum Vitae): A document detailing an investigator's professional and academic history, often required to be current for regulatory compliance in clinical trials.
• ICF (Informed Consent Form): A document signed by a participant in a clinical trial, indicating their voluntary agreement to participate after being fully informed about the study's nature, risks, and benefits.