eTMF Connect Demo | Document Authoring and Collaboration

This video provides an in-depth demonstration of the eTMF Connect solution, focusing specifically on the lifecycle of document authoring, collaboration, and filing within a regulated clinical trial environment. The demonstration follows the process from the perspective of David, a clinical author, who needs to upload and finalize a new study protocol document. The core objective of the system is to simplify the population of the Trial Master File (TMF) by centrally managing documentation within a pre-defined, compliant structure, ensuring that content is created, reviewed, and filed correctly from the outset.

The demonstration highlights the system's reliance on industry standards to enforce structure and compliance. eTMF Connect organizes clinical records using virtual cabinet drawers and process zones that are pre-defined and strictly aligned with both the DIA TMF Reference Model and the DIA EDM Reference Model. This structural alignment ensures that users are guided to the exact location where specific documents must reside. When David initiates the creation of a new protocol, the system presents a list of available document types for that specific section. Crucially, the system utilizes pre-defined templates, indicated by a Microsoft Word icon, which guarantees that the author begins with the correct format and required boilerplate content, mitigating errors and ensuring consistency across studies.

A key feature demonstrated is the seamless integration with Microsoft Word for authoring and collaboration. Upon selecting the protocol document type, the template opens directly in Word, with essential document properties and metadata pre-populated in a dedicated tab. Once the initial editing is complete, the author can immediately define the subsequent workflow steps, including specifying reviewers and approvers directly within the metadata bar, and assigning themselves as the document owner. When the document is checked back into the system, eTMF Connect automatically assigns a unique name and number, files it in the correct TMF location, and updates its status to "Draft."

The system excels in managing the collaborative review process. Once the document is checked in, all specified reviewers receive automated tasks, initiating the collaborative editing phase. The platform supports simultaneous tracking of edits, commenting, and acceptance/rejection of changes, all managed through the familiar Microsoft Word interface. This centralized feedback mechanism allows the document owner to consolidate all reviewer input into a single file, preparing the document for the final approval workflow. This streamlined process ensures efficiency and maintains a complete audit trail of all changes made during the critical drafting and review stages of clinical documentation.

Key Takeaways: • Regulatory Structure Enforcement: The eTMF system enforces compliance by aligning its document process zones and filing structure directly with the DIA TMF Reference Model and DIA EDM Reference Model, ensuring documents are categorized and stored correctly for regulatory inspection readiness. • Template-Driven Consistency: Utilizing pre-defined document templates (accessible via a Word integration) ensures that clinical authors start with the correct format and required content, significantly reducing the risk of non-compliant or incomplete documentation. • Metadata Automation: Document properties and metadata are pre-populated when a document is created from a template, automating the data entry process and ensuring accuracy before the author begins editing the core content. • Integrated Collaborative Editing: The platform facilitates real-time, simultaneous collaboration within the native Microsoft Word environment, allowing reviewers to track edits, leave comments, and manage changes efficiently without needing to export or re-upload files. • Automated Workflow Routing: Authors can define the entire review and approval workflow (specifying reviewers and approvers) directly within the document’s metadata, triggering automated task assignments upon check-in. • Unique Identifier Assignment: Upon saving or checking in a document, the system automatically assigns a unique name and number, standardizing nomenclature and simplifying document retrieval and tracking throughout the trial lifecycle. • Centralized Document Status Tracking: The system maintains clear visibility into the document lifecycle by automatically updating the status (e.g., "Draft") based on the current stage of the workflow, providing immediate context to all users accessing the TMF section. • Efficiency in Clinical Operations: By automating template generation, metadata entry, filing location, and workflow initiation, the system significantly reduces the manual effort and potential for human error associated with managing critical clinical documentation.

Key Concepts:

• eTMF (Electronic Trial Master File): A system used by life sciences companies to manage, store, and track essential clinical trial documents required for regulatory compliance.
• DIA TMF Reference Model: A standardized, hierarchical structure for organizing the TMF, widely adopted in the industry to ensure consistency and inspection readiness.
• DIA EDM Reference Model: The Drug Information Association's Electronic Document Management Reference Model, providing guidance on managing electronic regulatory submissions and documentation.
• Document Authoring and Collaboration: The process of creating, editing, reviewing, and approving documents, often involving simultaneous input from multiple team members while maintaining an auditable change history.

Tools/Resources Mentioned:

• eTMF Connect: The specific eTMF solution demonstrated.
• Microsoft Word: Used as the integrated authoring and collaborative editing tool.
• DIA TMF Reference Model: The foundational standard used for structuring the TMF within the system.