The TMF Reference Model is a reference system that eases the evaluation of clinical trials while maintaining regulatory requirements. Navigating the TMF Reference Model may seem difficult at first glance, but understanding the model’s history and structure will help provide some clarity.
It was developed in 2010 based on feedback from a panel of industry stakeholders comprised of more than 350 representatives from pharmaceutical companies, NGOs, and other medical industry groups.
The Drug Information Association (DIA) is tasked with maintaining the TMF Reference Model. The latest iteration of the system, version 3, was created by more than 100 individuals and company entities from around the world.
The steering committee oversees updates to the model. Members of this committee are democratically elected from a pool of members already registered with the DIA.
The TMF Reference Model is presented in a spreadsheet, which, along with the User Guide, can be downloaded here.
Every study that uses the TMF Reference Model must follow standard procedures. These procedures outline how metadata and taxonomy are collected, defined, and stored with consistent nomenclature. There are four main areas of the model:
The documents filed in a TMF (trial master file) are stored in specific zones. Each zone is then broken down into Artifacts, Sub-Artifacts, and Sections. The TMF Reference Model seems complex, but it is comparable to making sure that library books are on the correct shelves. It makes it easy for regulators to find what they are looking for.
The organization and widespread use of the TMF Reference Model creates an industry standard that all clinical trials can use. Before the TMF Reference Model was implemented, every clinical study used whatever filing system that they felt was best, which meant that they had different names for document types and different locations for storing them. People who moved from one study to another were forced to familiarize themselves with the new models before they could start working. Ensuring that the documentation method is standardized across the industry increases efficiency and reduces the error rate.
The TMF Reference Model provides clear instructions on which files should be included in the TMF and which ones shouldn’t. Anyone reading a company’s TMF report can be certain that it will have all the information necessary to make a conclusive decision about the results of a given study. Regulators are able to make decisions faster and without going through a lot of unnecessary information.
The files in a TMF based on the TMF Reference Model are easy to follow. One file may have over 250 pages and 40+ columns, but the information is organized in such a way that you can find what you are looking for quickly. You just need to be familiar with the nomenclature, ICH reference codes, and artifact names.
The system is useful for both simple and complex studies. Phase I studies are easy to collate, but studies that require multiple research centers are more data-intensive. The TMF Reference Model can be used for both cases, and the only difference will be the size of the trial master file.
Electronic Trial Master File (eTMF)
All eTMF systems are configured based on the TMF Reference Model, so prior to migrating to a new eTMF system is a great time to implement the model. Managing thousands of paper files associated with most TMFs is a daunting task prone to errors, oversight, and missing documents. eTMF software allows organizations that use the TMF Reference Model to improve their best practice approaches with the use of electronic storage.
Corementum understands the TMF Reference Model inside and out. We also offer full-service eTMF process planning and implementation. We guide our clients through the migration from a paper-based documentation system to an industry-accepted eTMF system, easing the transition and ultimately ensuring success. For more information about how Corementum can assist you with your eTMF needs, contact us.