The Trial Master File (TMF) comprises all those essential documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirement” (ICH Guideline for Good Clinical Practice, E 6, Section 8).
All sponsors, whether they are companies, institutions or individuals conducting clinical trials have to maintain a TMF for each trial. The sponsor would normally have their own unique TMF structure, as defined by their Standard Operating Procedures.
Until the DIA TMF reference model initiative, which is part of the Document and Record Management SIAC, started in 2009, there was no comprehensive common model for managing TMF documents in existence. Many functions and vendors contribute to a TMF for a clinical trial, and each has their own interpretation and processes for document management. Oversight of the content of the TMF on an ongoing basis is usually not one person’s or function’s responsibility, which results in additional complexity to achieve standardised output, even within the same organisation and across multiple studies. This situation was regarded as a highly inefficient way for the clinical research industry to work (Source: DIA TMF Reference Model Project 2009 project charter and scope).
The initial version 1.0 of the TMF reference model was released in June 2010. Version 2.0 of the TMF Reference Model was recently released on 25th June 2012 as a result of the on-going activities of the DIA Document and Records Management SIAC to address industry comments and to further expand the scope of the model. The enhancement within the new major release, Version 2.0, includes the definitions for Investigator Site Files, Investigator Initiated Studies, Process-based Metadata and Device Studies.