2018-09-10 TMF Reference Model General Meeting

This video provides an in-depth exploration of the TMF Reference Model, focusing on community updates, subgroup progress, and the release of version 3.1.0. The general meeting, held in September 2018, served as a platform for various working groups to present their advancements and solicit community involvement, highlighting the collaborative effort behind maintaining and evolving this critical standard for clinical trial documentation. The discussion underscores the model's role in standardizing Trial Master Files (TMFs) across the pharmaceutical and life sciences industries, addressing challenges related to document management, regulatory compliance, and digital information exchange.

The meeting progressed through several key updates, beginning with an overview of the TMF Reference Model community's growth, including new project team members, subscribers, and forum participants. Following logistical announcements, the core of the meeting involved detailed reports from specialized subgroups. These included updates on the Non-Interventional Study (NIS) TMF, which is being segmented into three categories for different study types; the Sub-Artifacts team, which is diligently defining sub-artifacts across various TMF zones and seeking additional reviewers; and the Device TMF group, which is reviewing zones to develop a high-level best practices guide and suggesting modifications to artifact names and commentary. A significant portion of the meeting was dedicated to the "Framework for the Destruction of Paper," detailing its project timeline, parameter review, and the development of implementation tools such as decision trees and policy templates, emphasizing the ongoing need for volunteers.

A crucial segment of the meeting focused on the Exchange Mechanism Standard (EMS) team, which had recently hosted a business-focused webinar and planned future technical and business webinars to encourage piloting of the EMS by CROs and sponsors. The highlight of the meeting was the announcement of the TMF Reference Model version 3.1.0 release by the Change Control Board (CCB). This "minor update," effective October 10th, incorporated 23 approved change requests out of 64 submitted since 2015. Key changes included the integration of dating conventions and milestones (country, trial, site levels) directly into the model, minor artifact name adjustments, updated definitions, the addition of a few sub-artifacts, correction of typographical errors, and updates to filing levels and alternate names. The meeting concluded with a discussion on the impact of this new version, emphasizing that while changes were minimal and primarily aimed at consistency, the stable artifact ID numbers ensure seamless data exchange and mapping, even with evolving artifact names.

Key Takeaways:

• TMF Reference Model as a Core Standard: The TMF Reference Model is a foundational standard for managing clinical trial documentation, crucial for regulatory compliance and operational efficiency within the pharmaceutical and life sciences sectors. Its continuous evolution reflects industry needs and best practices.
• Community-Driven Development: The model's development and updates are a collaborative effort, relying on a large community of volunteers, project teams, and subgroups. This ensures broad industry representation and practical relevance.
• Version 3.1.0 Release Details: The TMF Reference Model version 3.1.0 is a minor update, incorporating 23 approved change requests. Key enhancements include integrated dating conventions, country/trial/site level milestones, minor artifact name adjustments, and refined definitions to improve clarity and consistency.
• Stable Artifact IDs for Data Exchange: Despite changes to artifact names or definitions, the underlying artifact ID numbers remain constant. This is critical for data mapping, migration, and the interoperability of TMF systems, particularly when using the Exchange Mechanism Standard (EMS).
• Importance of Detailed Release Notes: Users are strongly encouraged to consult the detailed release notes for version 3.1.0, which provide comprehensive information on all changes, including old and new text, to understand the full scope of updates.
• Subgroup Progress and Future Outlook: Active subgroups are addressing specific areas such as Non-Interventional Studies (NIS), Device TMFs, and the comprehensive definition of sub-artifacts. These efforts are expected to lead to future major releases incorporating new frameworks and guidelines.
• Framework for Paper Destruction: A dedicated framework is being developed to guide the compliant destruction of paper TMF documents. This project involves creating tools like decision trees and policy templates, highlighting the industry's move towards digital solutions while managing legacy paper records.
• Exchange Mechanism Standard (EMS) Adoption: The EMS team is actively promoting the standard through webinars and seeking sponsors, CROs, and vendors to pilot its implementation. This initiative aims to standardize the digital exchange of TMF content between different organizations and systems.
• Call for Volunteers: The TMF Reference Model initiative consistently seeks volunteers for various roles, including reviewing sub-artifacts, participating in zone teams, and assisting with implementation projects like the paper destruction framework. This collaborative model is essential for its ongoing success.
• Impact of Minor Updates: Minor updates like version 3.1.0 are unlikely to cause significant incompatibility issues with previous versions. Organizations do not necessarily need to immediately update their systems but can incorporate changes during planned TMF structure reviews.
• Feedback and Change Request Process: The community is encouraged to submit feedback and change requests through a dedicated online forum, providing specific details (e.g., artifact numbers) to facilitate review by the Change Control Board. The forum is not for general questions, which should be directed to community groups.
• Consideration for Artifact-Level Versioning: A discussion point raised the potential for versioning at the individual artifact level, rather than just the entire reference model. While challenging for non-technical users or paper-based systems, this could be beneficial for eTMF systems capable of tracking granular changes.

Tools/Resources Mentioned:

• MailChimp (for mailing lists/newsletters)
• Yahoo Groups (for online discussions)
• Groups.IO (for project team members)
• TMF Reference Model Website (for general information, meeting details, and downloading ICS files)
• Outlook/Google Calendar (for importing meeting details via ICS files)
• Online Forum (for submitting feedback and change requests)

Key Concepts:

• TMF Reference Model: A standardized, hierarchical model for organizing and managing documents within a Trial Master File, ensuring consistency and regulatory compliance.
• Artifacts: Individual documents or records within the TMF, each assigned a unique ID number.
• Sub-Artifacts: More granular components or types of documents within a broader artifact category.
• Zones: High-level categories within the TMF Reference Model (e.g., Study Management, Central Trial Documents).
• Change Control Board (CCB): The governing body responsible for reviewing, approving, and managing changes to the TMF Reference Model.
• Exchange Mechanism Standard (EMS): A standard designed to facilitate the digital exchange and interoperability of TMF content between different systems and organizations.
• Non-Interventional Studies (NIS): Clinical studies where patients receive routine care, and data is collected without intervention, requiring specific TMF considerations.
• Device TMF: The Trial Master File specific to medical device studies, which may have unique documentation requirements compared to pharmaceutical trials.
• Framework for Destruction of Paper: A guideline or methodology for the compliant and systematic destruction of physical TMF documents, particularly relevant as organizations transition to electronic TMFs.
• Version Control (Maintenance, Minor, Major Changes): A classification system used by the CCB to categorize the impact and scope of updates to the TMF Reference Model.