Flex Databases eTMF – electronic Trial Master File

This video provides an in-depth demonstration of Flex Databases' electronic Trial Master File (eTMF) system, designed to offer comprehensive 24/7 visibility and management of all trial documentation within clinical research. The presentation walks through the system's user interface and core functionalities, emphasizing its role in streamlining clinical operations, ensuring data integrity, and maintaining regulatory compliance. The speaker's approach is a feature-by-feature walkthrough, showcasing how users can navigate, manage, and report on trial documents from a high-level dashboard down to individual file details, all while highlighting the system's configurability and user-centric design.

The demonstration begins with an overview of the cross-project dashboard, which presents customizable widgets and reports, along with a centralized area for eTMF messages and personal activities. This initial view allows users to quickly grasp their tasks and project statuses across all allocated projects. The system then transitions to a deeper dive into individual project work, illustrating how an eTMF provides an instant understanding of project progress through a structured view of document completion percentages and statuses. Key functionalities for document interaction are highlighted, including quick search filters, detailed document information (size, author, last updated), options for review, metadata management, and in-system editing and version control.

A significant portion of the demonstration focuses on the system's robust document handling and compliance features. This includes the ability to send documents directly from the system with an audit trail, OCR recognition for text search within scanned documents, and a secure recycle bin for deleted files. The video also details various upload methods, including drag-and-drop and email integration, and showcases the system's electronic signature capabilities, which add a compliant extra page with date, time, signatory, and reason. The presentation concludes with an exploration of reporting tools, including master reports and TMF fulfillment reports, and the administrative area for managing user permissions, configurable metadata sets, and document templates, such as those recommended by the DIA (Drug Information Association). The emphasis on comprehensive logging for archiving, emails, and electronic signatures underscores the system's readiness for audits and inspections.

Key Takeaways:

• Centralized Trial Documentation Management: The Flex Databases eTMF system offers a unified platform for managing all clinical trial documentation, providing 24/7 visibility and a "helicopter view" of eTMF processes, which is crucial for large-scale clinical operations.
• Customizable Dashboards and Reporting: Users are greeted with a personalized dashboard featuring configurable widgets and reports, allowing for immediate insights into cross-project activities, messages, and individual task lists, enhancing daily workflow efficiency.
• Granular Project Overview: Within individual projects, the system provides an instant understanding of progress through a structured view that displays document completion percentages and statuses, enabling proactive management and identification of bottlenecks.
• Advanced Document Interaction and Metadata Management: The eTMF supports comprehensive document lifecycle management, including quick search by various criteria (name, country, site, completeness, type), detailed document information, in-system editing, version control, and configurable metadata fields, some of which are auto-sourced.
• Integrated Communication and Collaboration: The system facilitates collaboration by allowing users to start chats or leave comments directly on documents, streamlining communication among team members and stakeholders.
• Robust Compliance and Audit Readiness: Critical compliance features include audit trails for sent documents, a secure recycle bin for deleted files (ensuring nothing is permanently lost), and comprehensive logs for archiving, emails, and electronic signatures, preparing organizations for audits and inspections.
• Compliant Electronic Signatures: The system generates electronic signatures that are compliant with regulatory requirements, adding an extra page to signed documents detailing the date, time (UTC), signatory name, and reason for signature (e.g., reviewed, approved).
• Efficient Document Upload and OCR: Multiple convenient methods for document upload are available, including drag-and-drop and emailing documents directly into the system, with automatic allocation based on email subject. OCR recognition enables full-text search within scanned documents, improving discoverability.
• Configurable Permissions and Access Control: The administrative area allows for detailed management of user permissions, enabling access rights to be set per user and per folder, ensuring data security and adherence to roles-based access control.
• Templates and Placeholders for Standardization: The system supports the use of templates, including those recommended by organizations like the DIA, and placeholders, which guide users on expected document types and naming conventions, promoting standardization and consistency across trials.
• Export and Archiving Capabilities: Users can export all documents from a project for offline work or download the entire TMF as a ZIP file with its original structure, providing flexibility for external review or long-term archiving.
• Dedicated Auditor/Inspection Access: A "TMF Master copies" section can be configured to provide auditors or inspectors with access only to final, approved documents, preventing them from seeing drafts or internal communications, thus streamlining the inspection process.

Tools/Resources Mentioned:

• Flex Databases eTMF: The primary electronic Trial Master File system demonstrated.
• Flex Databases CTMS, LMS, PM& Budgeting, EDC, Pharmacovigilance automation systems: Other products offered by Flex Databases, indicating a broader suite of clinical trial management solutions.
• HR database: A supportive module mentioned for sourcing email addresses when sending documents.
• DIA (Drug Information Association) templates: Referenced as a source for recommended document templates within the system.

Key Concepts:

• eTMF (electronic Trial Master File): A digital system for managing all essential documents of a clinical trial, ensuring they are complete, accurate, and readily available for regulatory inspection.
• Cross-project area: A centralized dashboard view that aggregates information and activities across all clinical projects a user has access to.
• Metadata: Data that provides information about other data. In an eTMF, this includes details like document author, date uploaded, version, and specific trial-related attributes, all of which are configurable.
• OCR (Optical Character Recognition): Technology that enables the system to recognize text within images or scanned documents, making the content searchable.
• Audit Trail: A chronological record of system activities, including document uploads, edits, deletions, and electronic signatures, essential for regulatory compliance and accountability.
• Electronic Signatures: Digital signatures that are legally binding and comply with regulatory requirements (e.g., 21 CFR Part 11), providing proof of review or approval with specific details like date, time, and reason.
• Placeholders: Predefined slots or markers within the eTMF structure that indicate where specific documents are expected, helping to track completeness and guide document submission.
• TMF Master Copies: A designated section within the eTMF, typically for final, approved documents, which can be selectively shared with external parties like auditors or regulatory inspectors.