Webinar: eTMF – automated oversight and quality review

This webinar provides an in-depth exploration of the electronic Trial Master File (eTMF) with a specific focus on automated oversight and quality review processes offered by Flex Databases. The presenters, Montasar (Project Manager) and Marietta (Sales and Product Marketing Team Lead), guide the audience through the evolution of TMF management towards a risk-based approach, emphasizing how automation can enhance efficiency, ensure regulatory compliance, and improve overall trial quality in clinical projects. The session highlights the practical application of their eTMF system through live demonstrations, showcasing features designed to streamline documentation, collaboration, and reporting within the pharmaceutical and life sciences sectors.

The presentation begins by establishing the foundational concept of a risk-based Trial Master File, defining it as a methodology for organizing and maintaining clinical trial documents with a focus on identifying and mitigating associated risks. It underscores the critical importance of ensuring trial quality, data integrity, patient well-being, and adherence to strict regulatory standards set by agencies like the FDA and EMA. The discussion then transitions to the tangible benefits of implementing such an approach, including enhanced efficiency through optimized resource allocation, improved risk management, and superior data quality. A significant portion of the webinar is dedicated to detailing the automated quality review process, which allows for advanced planning, systematic execution, and comprehensive reporting, thereby transforming TMF oversight from a burden into a collaborative and streamlined activity.

Through interactive polls and system demonstrations, the presenters illustrate how Flex Databases' eTMF solution facilitates the planning and execution of quality reviews. Users can pre-plan reviews, set due dates, assign responsibilities based on expertise (e.g., PMs for trial management folders, pharmacovigilance managers for safety reporting), and even specify the percentage of documents to be checked from selected folders, excluding previously reviewed items. The system enables reviewers to check document content and metadata, raise queries directly from the document card, and track query resolution. Furthermore, the webinar showcases integrated communication tools like chats and a dedicated query section, which foster real-time interaction and issue resolution. The session concludes with a demonstration of dynamic dashboards and visualizations that provide a holistic overview of TMF completeness, quality check results, and project status, offering actionable insights for stakeholders.

Key Takeaways:

• Risk-Based TMF Approach: A risk-based Trial Master File methodology is crucial for organizing and maintaining clinical trial documents by proactively identifying and mitigating risks, ensuring quality, integrity, and patient well-being.
• Regulatory Compliance: Adherence to strict quality standards mandated by regulatory agencies like the FDA and EMA is paramount to avoid delays, fines, or trial rejections, with the eTMF system designed to support these requirements.
• Enhanced Efficiency: Implementing a risk-based TMF approach allows for more focused and efficient allocation of resources, structured TMF management, and streamlined processes, preventing unnecessary resource expenditure on low-risk activities.
• Automated Quality Review Planning: The Flex Databases eTMF system enables users to plan quality reviews in advance, including setting start/due dates, assigning specific team members, and defining the percentage of documents to be checked from selected folders.
• Intelligent Document Selection: The system intelligently excludes documents that have been previously reviewed from new quality review batches, ensuring that efforts are focused on new or updated content and increasing the overall coverage of checked documents.
• In-System Document Interaction: Reviewers can perform all necessary checks directly within the system, including viewing document content, verifying metadata (e.g., due date, expiration, country allocation), and raising queries for clarification or correction.
• Integrated Query Management: Queries can be raised directly from the document card, assigned to responsible team members with due dates, and tracked for resolution, facilitating timely issue identification and closure.
• Automated Reporting for Audits: The system automatically generates comprehensive quality review reports, detailing all checked folders and documents, and indicating the status of any queries (resolved/unresolved), providing documented evidence for audits and inspections.
• Real-time Collaboration Tools: Integrated chat and query functionalities within the TMF module facilitate real-time interactions, data clarification, and issue resolution, enhancing communication and overall trial efficiency.
• Comprehensive Dashboards and Visualizations: The eTMF module offers dynamic dashboards and graphs that provide a complete overview of study progress, TMF completeness by folders and totals, and quality check results, aiding in strategic decision-making.
• Configurable System Flexibility: The Flex Databases eTMF is highly configurable, allowing companies to apply their own templates, create custom workflows, and define specific metadata sets to meet unique organizational needs.
• Roadmap Driven by Client Feedback: The development roadmap for Flex Databases' solutions is directly influenced by client requests and feedback, ensuring that new features address real-world needs and challenges.
• Handling of Locked Documents and Placeholders: The system allows queries to be raised for locked documents (with a process for unlocking via help desk) and includes empty placeholders in reviews to ensure all required documentation is addressed.

Tools/Resources Mentioned:

• Flex Databases eTMF
• Flex Databases CTMS (Clinical Trial Management System)
• Flex Databases Pharmacovigilance
• Flex Databases QMS (Quality Management System)

Key Concepts:

• eTMF (electronic Trial Master File): A digital repository for essential documents of a clinical trial, ensuring compliance and data integrity.
• Risk-based TMF: A methodology for managing TMF documents that prioritizes identifying and mitigating risks associated with the clinical trial process.
• Quality Review: A systematic process of evaluating various aspects of a clinical trial, including documentation, to ensure adherence to predefined quality standards, regulatory requirements, and best practices.
• Placeholders: Designated slots within the TMF structure for documents that are expected to be uploaded.
• Metadata: Data that provides information about other data, such as document type, author, creation date, and associated milestones.