eTMF Connect Demo | Batch Indexing and Uploading Documents

This video provides a demonstration of the bulk upload and batch indexing capabilities within the eTMF Connect solution, focusing on streamlining the process of ingesting clinical trial documentation. The context is set within the "clinical inbox," a designated entry point for documentation sent to specific study and site email inboxes. The core objective of the workflow is to efficiently classify, index, and automatically route large volumes of documents to their correct locations within the Trial Master File (TMF), ensuring compliance and audit readiness. The demonstration highlights how the system minimizes manual effort and the risk of human error associated with repetitive metadata entry.

The workflow begins with a user, "David," navigating to the clinical inbox for his study. He initiates the bulk upload by dragging and dropping multiple files from his desktop into the working area. Once the upload is complete, the critical step of classification begins. Using the batch indexing feature, David selects all newly uploaded documents and activates an indexing wizard. This wizard is designed to handle common metadata fields across all selected documents simultaneously, a significant time-saver. For instance, if all documents pertain to the same study or site, that information is entered once and applied universally.

A key feature demonstrated is the ability to lock common metadata while allowing for document-specific classification. The presenter illustrates that while general metadata (like study ID) is locked, David can navigate through each document individually within the wizard to input unique details, such as specific approval dates or version numbers. Once the indexing is finalized, the system leverages a central component called the "file plan." The file plan is described as a comprehensive, industry-standard list of all required document types and content types within the TMF. The system uses the newly classified metadata to consult the file plan, automatically determining the correct routing and filing location for each document. This automated routing ensures that documents are placed according to regulatory and organizational standards, moving them out of the temporary clinical inbox and into the permanent, structured TMF library.

Key Takeaways: • Efficiency in Clinical Document Ingestion: The primary value proposition of the batch indexing feature is the dramatic reduction in time required to process incoming clinical documentation, moving away from single-document uploads and indexing toward scalable bulk processing. • Minimizing Repetitive Data Entry: The batch indexing wizard allows users to apply common metadata (e.g., study ID, site number) across multiple documents simultaneously, eliminating the need to repeatedly input identical information and reducing the likelihood of transcription errors. • Structured Metadata Classification: The system supports a hybrid indexing approach where common metadata can be locked, ensuring consistency, while allowing for granular, document-specific metadata (like approval dates or version numbers) to be added individually within the same workflow. • Automated Routing via File Plan: The system relies on a central, industry-standard "file plan" to automatically route documents based on the metadata classified during the indexing process. This ensures that documents are filed in the correct TMF structure, critical for GxP compliance and audit readiness. • Importance of the Clinical Inbox: The clinical inbox serves as a critical staging area and entry point for external documentation, often received via study or site-specific email addresses, providing a controlled environment before documents are formally committed to the TMF. • Compliance and Standardization: By utilizing a standardized file plan and enforcing metadata classification before filing, the system helps life sciences organizations maintain a compliant and standardized TMF structure, which is essential for regulatory inspections (e.g., FDA, EMA). • Relevance to AI Integration: The highly structured nature of this eTMF workflow (metadata-driven classification and routing) creates an ideal environment for integrating AI/LLM solutions. IntuitionLabs.ai could leverage this structure to build AI agents that automatically extract metadata from incoming documents in the clinical inbox, pre-populating the indexing wizard and further automating the classification process. • Data Engineering Foundation: The reliance on a robust "file plan" and structured metadata emphasizes the need for strong data engineering practices to maintain the integrity of the TMF structure and ensure accurate routing and retrieval of clinical data.

Tools/Resources Mentioned:

• eTMF Connect (Montrium)
• Clinical Inbox
• Indexing Wizard
• File Plan (Central list of document types/content types)

Key Concepts:

• eTMF (Electronic Trial Master File): A system used by sponsors and CROs to manage essential clinical trial documentation in a compliant, centralized, and standardized manner.
• Batch Indexing: The process of classifying and applying metadata to multiple documents simultaneously, significantly speeding up the documentation workflow.
• Clinical Inbox: A temporary holding area or staging environment where incoming clinical documents are collected, reviewed, and prepared for formal classification and filing into the TMF.
• File Plan: A predefined, hierarchical structure based on industry standards (like the TMF Reference Model) that dictates where specific document types must be filed within the eTMF system for regulatory compliance.