A Day In the Life of Wingspan eTMF

This video provides an in-depth exploration of the Wingspan eTMF (electronic Trial Master File) system, demonstrating its functionality through the typical daily tasks of a study owner and a Clinical Research Associate (CRA). The primary purpose is to showcase how Wingspan eTMF streamlines the management of clinical trial documents, ensuring efficiency, quality, and compliance throughout the study lifecycle, from setup to closeout. The presentation highlights the system's intuitive interface, robust workflow capabilities, and comprehensive tracking features designed to provide real-time insights into study health and document status.

The demonstration begins with Mary Murphy, a study owner, logging into the eTMF system. Her personalized dashboard immediately presents critical information, including general and study-specific announcements, personal notes, a summary of tasks in her inbox, documents in her work area, and a list of her active studies. This dashboard emphasizes proactive issue identification, displaying visual indicators for the completeness, quality, and timeliness of each study, which are crucial critical quality measures for eTMFs. Mary's ability to drill down into these indicators, for instance, to understand why a study is lagging in completeness by site, underscores the system's analytical depth and its capacity to generate actionable reports for problem-solving and collaboration.

The narrative then shifts to Francis O'Brien, a CRA, illustrating the document submission and rework process. Francis receives an email notification about a document returned for rework due to missing information, with a direct link to the task in the eTMF. This seamless integration facilitates quick corrections and re-submission to QC. The video further demonstrates Francis uploading a new financial disclosure document into a pre-existing placeholder, highlighting the efficiency gained from pre-defined metadata and the system's ability to automatically transform Word documents into PDF renditions while retaining the original format. The final indexing process, guided by organizational instructions, ensures accurate metadata assignment, including document dates, receipt dates, and crucial expiration dates, which the system uses to schedule future replacement documents. The workflow concludes with Ned, a QC user, reviewing documents, marking them as final, or failing them back with specific codes and comments, ensuring all necessary documents are complete and compliant for critical milestones like site initiation.

Key Takeaways:

• Centralized eTMF for Clinical Operations: The Wingspan eTMF serves as a single, centralized repository for all clinical trial documents, crucial for maintaining regulatory compliance and operational efficiency across studies.
• Role-Based Dashboards for Proactive Management: Study owners receive personalized dashboards providing immediate insights into study health (completeness, quality, timeliness), task summaries, and announcements, enabling proactive identification and resolution of issues without extensive reporting.
• Drill-Down Capabilities for Issue Resolution: Users can click on health indicators to drill down into detailed reports, such as breaking down document completeness by site, to pinpoint specific areas of concern and understand root causes of delays.
• Streamlined Document Rework Workflows: The system facilitates efficient document rework by sending automated email notifications to CRAs with direct links to tasks, detailed feedback on errors (e.g., missing phone numbers), and the ability to upload corrected versions quickly.
• Efficient Document Upload with Placeholders and Metadata: Documents can be easily uploaded into pre-defined placeholders, which come with extensive pre-populated metadata, significantly reducing manual data entry for CRAs and ensuring consistency.
• Automated Document Rendition and Retention: The eTMF automatically transforms uploaded documents (e.g., Word) into PDF renditions while retaining the original file, ensuring accessibility and archival integrity.
• Structured Quality Control (QC) Process: A robust QC process is integrated, allowing reviewers to assess content and metadata accuracy, provide specific feedback codes and comments for rejected documents, and mark documents as final.
• Metadata-Driven Document Management: Accurate metadata assignment, guided by organizational instructions, is critical for document searchability, compliance, and automated processes like tracking expiration dates.
• Automated Expiration Date Tracking: The system tracks document expiration dates and automatically schedules replacement tasks, ensuring that critical documents remain current and compliant throughout the study.
• Ensuring Site Initiation Readiness: The eTMF facilitates the collection and finalization of all necessary documents required for critical milestones like site initiation, ensuring that studies can proceed without compliance-related delays.
• Integration Potential: The system can source key study information from a CTMS (Clinical Trial Management System), suggesting potential for broader data integration across clinical operations platforms.

Tools/Resources Mentioned:

• Wingspan eTMF: The primary electronic Trial Master File system demonstrated.
• CTMS (Clinical Trial Management System): Mentioned as a potential source for key study information.
• Excel: Used for generating and sharing reports.

Key Concepts:

• eTMF (electronic Trial Master File): A digital system for managing and storing essential documents of a clinical trial, critical for regulatory compliance and audit readiness.
• Study Owner: A user role responsible for setting up, monitoring, maintaining, and closing out a set of studies within the eTMF.
• CRA (Clinical Research Associate): A user role responsible for tasks like document collection, upload, and ensuring site-level compliance.
• Completeness, Quality, Timeliness: Key performance indicators used to assess the health and status of a clinical study within the eTMF.
• QC (Quality Control): A process within the eTMF workflow to review documents for correctness, completeness, and adherence to standards before finalization.
• Site Initiation: A critical milestone in a clinical trial where a study site is formally approved to begin enrolling patients, requiring a complete set of finalized documents.
• Metadata: Descriptive information about a document (e.g., date, author, type, expiration date) that facilitates organization, search, and compliance.
• Placeholders: Pre-defined slots within the eTMF for specific documents, often pre-populated with metadata, to guide document upload and ensure proper categorization.