eTMF Connect Demo | Revising Clinical Documentation

This video demonstrates the compliant electronic workflow for revising clinical documentation within eTMF Connect, an Electronic Trial Master File (eTMF) solution tailored for the life sciences sector. The demonstration establishes the critical need for a controlled revision process, acknowledging that clinical studies and organizational requirements frequently necessitate changes to existing documentation. The platform is positioned as a tool that centralizes and standardizes clinical records, facilitating real-time access and contribution for both sponsors and Contract Research Organizations (CROs) while maintaining regulatory integrity.

The core of the demonstration focuses on the user experience of initiating a change. The process begins with the authorized user navigating to the document library and utilizing a context menu to trigger a dynamic revision request form. A key efficiency feature highlighted is the system's ability to automatically pre-populate the form with existing metadata from the document being revised, minimizing manual entry and ensuring accuracy. The user is then required to formally document the rationale for the revision, specify the type of change, and designate a revision request approver, formalizing the justification for the change before any physical editing occurs.

Once the revision request is submitted, the system initiates a dedicated workflow. This workflow’s primary purpose is to manage the transition of the document from a controlled, read-only state (typically PDF) to an editable format (such as Word). This controlled unlocking mechanism is essential for maintaining GxP compliance, ensuring that unauthorized changes cannot be made. Upon successful completion of this initial approval workflow, the original word document is unlocked, allowing the user to make the necessary content edits. The final step demonstrated is the initiation of the subsequent, separate Review and Approval workflow, which validates the revised content before the document is finalized, re-controlled, and archived within the eTMF system, ensuring a complete and auditable history of the document's lifecycle.

Key Takeaways:

• Mandate for Electronic Change Control: The necessity for revising clinical documentation due to evolving study protocols or organizational shifts mandates the use of a robust, electronic change control system to ensure all modifications are tracked, justified, and compliant with regulatory standards.
• Streamlined Initiation via Dynamic Forms: The platform utilizes dynamic revision request forms that capture essential metadata (rationale, revision type) upfront, formalizing the change control process immediately and providing the necessary justification for audit trails.
• Metadata-Driven Efficiency: The automatic pre-population of revision request forms with existing document metadata significantly enhances data accuracy and operational efficiency by reducing the need for manual transcription of document details.
• Controlled Document State Transition: The system enforces a critical control point by managing the transition of documents from a controlled, read-only state (e.g., PDF) to an editable format (e.g., Word) only after the formal Revision Request Workflow has been approved.
• Segregation of Approval Workflows: The revision process is structured into two distinct, auditable workflows: the initial Revision Request Approval (authorizing the edit) and the subsequent Content Review and Approval (validating the changes), ensuring clear separation of duties and comprehensive tracking.
• Importance of Approver Designation: Users must designate a specific revision request approver, establishing accountability and ensuring that the decision to unlock and modify the clinical document is formally documented and authorized before editing commences.
• Support for Sponsor/CRO Collaboration: The eTMF solution is designed to centralize and standardize clinical records, enabling seamless and compliant contribution and access for both the trial sponsors and their contracted CROs in real-time.
• Auditability and Compliance Foundation: The entire electronic process—from the initial request to the final saving of the revised document—is engineered to maintain a complete audit trail, satisfying stringent regulatory requirements related to document control and data integrity (critical for GxP and 21 CFR Part 11 adherence).

Tools/Resources Mentioned:

• eTMF Connect: A specialized Electronic Trial Master File (eTMF) solution for life sciences companies, provided by Montrium.

Key Concepts:

• eTMF (Electronic Trial Master File): The digital repository for all essential documents related to a clinical trial, required for regulatory compliance and reconstruction of the trial history.
• Revision Request Rationale: The required justification provided by the user explaining why a change to a controlled clinical document is necessary, forming a key component of the audit trail.
• Workflow Management: The automated routing and tracking of documents through predefined steps (editing, review, approval) to ensure compliance, consistency, and timely completion of regulated tasks.