What is the TMF Reference Model?

The Trial Master File Reference Model (TMF reference model) was created over 10 years ago with support from the Drug Information Association (DIA) Document and Records Management Community to create a unified and standardised approach to the way in which Trial Master File (TMF) documentation is stored and structured.

The model covers the full scope of the essential document list as described in ICH E6 Good Clinical Practice Guidelines but more comprehensively adds a wide range of other documents that allow verification of the conduct of a clinical trial and the quality of the data generated. It has become a standard , the definitive set of guiding principles that help simplify and bring structure to the management of the TMF.

Though not endorsed by regulatory agencies, the TMF reference model is used as the baseline architecture for electronic trial master file technologies and is recognised by inspectors who are wholly familiar with the approach.

What is the purpose of the model?

• Firstly, industry agreement on which documents should and should not be stored within the TMF.
• Secondly, a unified structure to support both paper and electronic systems so that all trial master files look the same.
• Thirdly, consistent naming conventions.
• And finally, application of a standard metadata structure to enable easy and efficient search and location of documents.

 
This standardised approach ensures that those who require access (alongside auditors and inspectors) are able to search, locate and retrieve what they are looking for in a seamless and efficient manner. In doing so, many benefits are realised, such as:

• Introduces operational efficiency and accelerates progress improving the TMF management processes.
• Encourages systematic and consistent approaches to data and documents management that improve clarity, context and understanding.
• Simplifies and reduces the administrative burden.
• Makes TMF content instantly accessible to external parties such as inspectors.
• Eases the interchange of documents between eTMF systems.
• Provides greater opportunities for real-time collaboration between sponsor and partnering organisations (e.g. CRO) and enhances sponsors’ supervision and oversight of activities.
• Establishes a standardised framework to better guarantee TMF quality .
• Reduces duplication of TMF data and documents.
• Aligns with industry standards, applicable regulations, and recognised best practice.

 
Since its inception, the model has continued to be developed. In 2020, version 3.2.0 was published to reflect updated regulatory guidance and industry best practices.

Arkivum’s solution adheres to the TMF Reference Model and EMS. To learn more about how our service can help unify your documents and ensure you’re complying with regulations, contact us today.