Vault eTMF Viewer Demo

This video provides a concise demonstration of the Veeva Vault eTMF Viewer, a feature designed to streamline the management and navigation of Trial Master File (TMF) content within Veeva's clinical vault environment. The primary purpose of the eTMF Viewer is to offer a dynamically organized, user-friendly interface for browsing, searching, and filtering TMF documents, significantly reducing the administrative burden associated with traditional binder creation and maintenance. The presenter emphasizes its utility for supporting regulatory inspections, allowing both inspectors and study personnel to efficiently navigate the TMF content.

The demonstration begins by illustrating how users can access the TMF Viewer via the study management tab within their clinical vault. It highlights the ability to filter content by study, study country, and study site, enabling users to drill down to granular levels of information. A key feature showcased is the dynamic folder structure on the left-hand side, which intelligently adjusts to display only sections containing actual content, thereby preventing confusion from empty folders. The video further details the flexibility in viewing document structures, allowing users to select from various TMF Reference Model versions or Veeva's proprietary "Veeva Clinical Docs" hierarchy. The "expand all" button is presented as a useful tool for quickly viewing all subsections within folders.

The core functionality for efficient TMF management is demonstrated through practical use cases. The presenter illustrates how a study manager can utilize the search bar to find specific documents, such as investigator CVs, and then apply advanced filters, like sorting by expiration date, to identify documents requiring immediate action (e.g., expired CVs). Another example shows how to locate all informed consent forms, with the ability to expand and view different versions of a document. A crucial aspect highlighted is that the eTMF Viewer respects security and permissions, ensuring users only access documents they are authorized to view. Finally, the video demonstrates the capability to take direct actions on documents from within the viewer, such as logging a quality issue, and the convenient feature of exporting document lists to Excel with hyperlinks that lead directly back to the documents in Vault, enhancing traceability and auditability.

Key Takeaways:

• Centralized TMF Management: The Veeva Vault eTMF Viewer provides a centralized, electronic platform for managing Trial Master File content, moving away from manual binder creation and maintenance, which significantly reduces administrative overhead.
• Enhanced Inspection Readiness: The viewer is specifically designed to support regulatory inspections by offering dynamically organized content and flexible navigation options, accommodating both self-guided inspector navigation and guided tours by study personnel.
• Dynamic Content Organization: TMF content is dynamically organized, and users can switch between multiple configured hierarchies, including various TMF Reference Model versions and Veeva's own "Veeva Clinical Docs" structure, to suit specific viewing preferences or regulatory requirements.
• Granular Filtering and Navigation: Users can filter TMF content by study, study country, and study site, allowing for precise drill-down capabilities to access relevant documents efficiently. The folder structure intelligently displays only sections with content, avoiding visual clutter from empty folders.
• Powerful Search and Advanced Filtering: The integrated search bar, combined with advanced filtering capabilities (e.g., by expiration date), enables proactive TMF management. For instance, study managers can quickly identify and act on documents like investigator CVs nearing or past their expiration dates.
• Security and Permissions Enforcement: The eTMF Viewer strictly adheres to security and permission settings, ensuring that users can only view and interact with documents for which they have explicit authorization, maintaining data integrity and compliance.
• In-Viewer Document Actions: Users can perform various actions directly from within the viewer, such as logging a quality issue related to a specific document, streamlining workflows and reducing the need to navigate away from the TMF interface.
• Export with Hyperlinks for Auditability: The ability to export lists of documents to Excel, with embedded hyperlinks that lead directly back to the respective documents within Veeva Vault, greatly enhances auditability, collaboration, and external sharing while maintaining traceability.
• Support for Critical Clinical Operations: The viewer facilitates efficient management of essential clinical documents, such as informed consent forms, by allowing users to easily search, view versions, and ensure all necessary documentation is in order.

Tools/Resources Mentioned:

• Veeva Vault eTMF Viewer
• Veeva Clinical Vault
• TMF Reference Model
• Veeva Clinical Docs

Key Concepts:

• TMF (Trial Master File): A collection of essential documents that individually and collectively permit the reconstruction and evaluation of the conduct of a clinical trial.
• eTMF (electronic Trial Master File): The digital equivalent of a paper TMF, managed through specialized software like Veeva Vault, offering enhanced searchability, security, and compliance features.
• TMF Reference Model: An industry-standard, universally accepted taxonomy and metadata for the TMF, providing a standardized structure for TMF content.
• Clinical Vault: Refers to Veeva's cloud-based content and data management solution specifically tailored for clinical operations in the life sciences industry.
• Inspection Readiness: The state of being prepared to present TMF documentation to regulatory authorities during an inspection, demonstrating compliance with good clinical practice (GCP) and other regulations.