IQVIA Technologies eTMF demo

This video provides an in-depth demonstration of the IQVIA Technologies eTMF (electronic Trial Master File) system, presented by Charles Patrell, a Solutions Engineer at IQVIA. The primary purpose of the demo is to showcase how the eTMF facilitates inspection readiness, drives quality and completeness, and ensures timeliness in managing Trial Master Files for clinical studies. The system is presented as a rule-based platform, granting specific rights and permissions to users, and its structure is based on the industry-standard TMF Reference Model, which is fully configurable to meet individual customer needs.

The demonstration begins with an overview of the user's personalized homepage, which serves as a central hub for managing eTMF activities. This dashboard displays announcements, personal notes for follow-up, and an inbox for assigned tasks such as document rework or approval requests. A "work area" highlights documents in draft or unfinished states, emphasizing the system's "eTMF as a factory" concept, where continuous movement of documents is crucial to prevent backlogs. The homepage also features a study grid dashboard, allowing users to monitor the TMF health of their favorite studies and those recently accessed, with information integrated from CTMS (Clinical Trial Management System) and supported by study setup wizards.

A significant portion of the demo focuses on the system's ability to track and analyze TMF health through key performance indicators (KPIs): completeness, quality, and timeliness. Completeness measures the percentage of finalized documents against those due by a specific date, quality assesses rework rates during the QC process, and timeliness tracks prompt document finalization. Users can drill down into a completeness dashboard for a specific study, comparing its performance against others in their portfolio and analyzing missing document statuses by country, site, organization, or risk level. The video also illustrates a streamlined document submission process, utilizing planned placeholders that automatically apply metadata, reducing manual data entry. Documents can be reviewed, assigned dates, and finalized, with the option for a risk-based specialist review before finalization. The system offers various views, including a folder tree structure for navigating by Zone, Section, and Artifact, alongside robust search and filtering capabilities, and the ability to export study items to Excel for authorized users. Finally, a study timeline feature allows users to visualize events and associated documents, enhancing oversight of trial progression.

Key Takeaways:

• Centralized TMF Management for Inspection Readiness: The IQVIA eTMF functions as a comprehensive system designed to maintain Trial Master Files in an "inspection ready" state at all times, ensuring compliance with regulatory authorities.
• Rule-Based System with Configurable Structure: The eTMF employs a rule-based permission system and its structure is built upon the industry-standard TMF Reference Model, offering extensive configurability to adapt to specific customer requirements.
• User-Centric Homepage and Workflow Management: The system provides a personalized user homepage displaying critical information such as announcements, personal notes, and an inbox for assigned tasks, streamlining individual workflow and task prioritization.
• "eTMF as a Factory" Concept: The platform promotes a continuous workflow, conceptualizing the eTMF as a "factory" where documents must consistently move forward to prevent backlogs and ensure efficient trial conduct.
• KPI-Driven TMF Health Monitoring: The eTMF utilizes a "Quality by Design" approach to define and track key performance indicators (KPIs) for TMF health, specifically completeness (finalized documents vs. due), quality (rework rates), and timeliness (prompt finalization).
• Granular Completeness Analysis: Users can access detailed completeness dashboards to compare study performance, identify missing documents, and analyze status breakdowns by country, site, organization, or risk level, enabling targeted intervention.
• Streamlined Document Submission: The system facilitates efficient document submission through pre-planned placeholders, which automatically apply relevant metadata (e.g., study, country, site, document type), significantly reducing manual data entry and potential errors.
• Risk-Based Document Review and Finalization: The eTMF supports a structured document review and finalization process, including the option to implement a risk-based approach requiring specialist review for critical documents before finalization.
• Multiple Viewing and Navigation Options: Users can view TMF items in various formats, including a detailed item list and a hierarchical folder tree structure (Zone, Section, Artifact), catering to different navigation preferences.
• Advanced Search and Filtering Capabilities: The system offers robust search functionality, allowing users to search by keyword across metadata, content, or both, complemented by extensive filters (facets) to refine results, similar to e-commerce platforms.
• Study Timeline for Event Tracking: A dedicated study timeline feature provides a chronological view of events that have occurred during a study, enabling users to quickly identify and review documents associated with specific milestones or changes.
• Integration with CTMS: The eTMF integrates with Clinical Trial Management Systems (CTMS) to import study information and leverage industry-leading study setup wizards, simplifying the process of determining required documents for regulatory compliance.

Tools/Resources Mentioned:

• IQVIA eTMF: The core electronic Trial Master File system demonstrated.
• CTMS (Clinical Trial Management System): Mentioned as a source for integrating study information into the eTMF.
• Excel: Authorized users can export all study items to Excel for further analysis.

Key Concepts:

• eTMF (electronic Trial Master File): A digital system for managing all essential documents of a clinical trial, crucial for regulatory compliance and audit readiness.
• TMF Reference Model: An industry standard for structuring the content of a Trial Master File, ensuring consistency and completeness.
• Inspection Readiness: The state of having all necessary documentation organized, complete, and readily accessible to satisfy regulatory authority inspections.
• Quality by Design (QbD): An approach to defining and monitoring KPIs within the eTMF, ensuring that the system is designed to achieve desired quality outcomes from the outset.
• KPIs (Key Performance Indicators): Specific metrics used to evaluate the health and efficiency of the TMF, including Completeness, Quality (rework rates), and Timeliness.
• Placeholders: Empty document slots created during the TMF planning process, which, when populated, automatically apply associated metadata, streamlining document submission.