The Trial Master File (TMF) Reference Model consists of standardized taxonomy that outlines the clear definition and organization of TMF content using standard nomenclature. This model, developed by a working group of the DIA Document Management Special Interest Area Community (SAIC), is a reference for the industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry. The TMF Reference Model can be adapted equally to an electronic or a paper TMF. It does not endorse, nor by design, require, any specific technology for application. The model can be downloaded HERE.
The TMF Reference Model presents a consensus position of the TMF Reference Model Team regarding the content of the TMF to include all essential documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced, in accordance with regulatory requirements, industry opinion and best practices. The TMF Reference Model team is composed of approximately 274 representatives from more than 165 bio-pharmaceutical companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia, not-for-profit / NGO and regulatory agencies.
V1.0 of the TMF Reference Model, first released in June of 2010, was updated in February, 2011 (V1.1) and again in December, 2011 (V1.2), based on feedback provided as the model was widely implemented.
Who Benefits from the TMF Reference Model?
- Biopharmaceutical sponsor companies of any size, both commercial and institutional, involved in clinical trials.
- Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.
- Contract Research Organizations and vendors supporting TMFs.
- TMF Consultants.
- Site staff, including investigators and coordinators.
- Regulators challenged with varying TMF terminology and file structures, which create inefficiency and a higher degree of variability during sponsor audits
V2.0 includes additional details for Investigator Site Files, Device Studies, Investigator Initiated Studies, and Process-based metadata.
You can participate in discussions related to the TMF Reference Model by joining the LinkedIn group.