MasterControl eTMF Manager

This video provides a detailed overview of the MasterControl eTMF Manager, a specialized software solution designed to streamline the management of the electronic Trial Master File (eTMF) throughout the clinical trial lifecycle. The primary context established is the common, costly mistake organizations make by implementing disparate, disconnected applications to handle various aspects of their clinical trials. MasterControl positions its eTMF Manager as a unified, integrated platform capable of managing all TMF documentation, related processes, tasks, and milestones within a single system, thereby improving efficiency, collaboration, and transparency for sponsors, CROs, and clinical study sites.

The core functionality of the eTMF Manager is built upon the industry-standard DIA TMF Reference Model structure. This framework serves as a foundational template and checklist for every new study, ensuring that all necessary study artifacts and tasks are accounted for from the outset. The system is designed with various clinical research roles in mind—including clinical directors, clinical research associates, and principal investigators—to facilitate the planning, assigning, creating, reviewing, and approving of the hundreds of TMF artifacts generated throughout a study’s duration. A critical component highlighted is the automated document routing and approval capabilities, which are essential for maintaining regulatory adherence.

A significant emphasis is placed on regulatory compliance, specifically mentioning that the solution ensures electronic signatures and audit trails are maintained in strict accordance with 21 CFR Part 11 requirements. Operationally, the eTMF Manager provides configurable TMF views that can be filtered by status and assignments, offering real-time visibility into clinical study activities. Each TMF artifact within the system includes configurable attributes—such as name, taxonomy, default document type, and custom fields—which control the document's lifecycle, authorization templates, and workflow routes. This level of customization and control ensures that both internal users and external parties (like CROs and site users) can efficiently manage their assigned tasks, upload or create documents, and proceed through predefined workflow routes, ultimately bringing all TMF documentation and operations together under a unified platform.

Key Takeaways: • Unified Clinical Management Platform: The primary value proposition is solving the problem of disconnected applications by offering a single, integrated platform for TMF documentation, tasks, milestones, and related processes, which is crucial for reducing administrative overhead and improving data integrity. • DIA TMF Reference Model Foundation: The system utilizes the DIA TMF Reference Model as a standardized template for launching new TMF projects, ensuring comprehensive coverage and serving as an outline and checklist for all required study artifacts and tasks. • Regulatory Compliance (21 CFR Part 11): The platform is explicitly designed to meet stringent regulatory requirements by automating document routing, approval workflows, and maintaining robust electronic signatures and immutable audit trails, which is non-negotiable for FDA-regulated clinical data. • Role-Based Efficiency: The solution caters specifically to key clinical research roles (Clinical Directors, CRAs, PIs) by streamlining processes, tasks, and document management generated before, during, and after a clinical trial, enhancing collaboration across the ecosystem. • Real-Time Visibility and Tracking: The eTMF Manager provides TMF views that can be filtered by status and assignments, offering sponsors and CROs real-time visibility into the progress of pending, ongoing, and completed actions across all clinical study activities. • Configurable Artifact Management: TMF artifacts are highly configurable, allowing organizations to define artifact names, taxonomy, default document types, and custom fields, which in turn control the default rights, lifecycle, and document authorizing templates for precise control over data governance. • External User Collaboration: The system supports setting TMF artifact assignments for users both internal and external to the organization (e.g., CROs and site personnel), facilitating seamless collaboration and ensuring all parties are notified of and can execute their assigned tasks within the regulated environment. • Automated Workflow and Completion: Users are notified of task assignments and can proceed through predefined workflow routes for uploading, creating, reviewing, and approving TMF artifacts; upon completion, the content automatically appears in the TMF management view as complete, minimizing manual status updates.

Tools/Resources Mentioned:

• MasterControl eTMF Manager
• MasterControl Clinical Excellence™ (suite of products)

Key Concepts:

• eTMF (Electronic Trial Master File): The digital repository for essential documents and records related to a clinical trial, necessary for reconstruction, management, and inspection of the trial.
• DIA TMF Reference Model: A standardized, structured model for organizing and filing TMF documents, widely adopted in the pharmaceutical industry to ensure consistency and completeness.
• 21 CFR Part 11: The FDA regulation governing the use of electronic records and electronic signatures, requiring systems to ensure trustworthiness, reliability, and equivalence to paper records and handwritten signatures.
• CROs (Contract Research Organizations): Third-party organizations that manage clinical trials and research activities on behalf of pharmaceutical or biotech sponsors.