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.

The ADAMAS Corporate Brochure 2016


Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

Regulatory Environment


The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.



ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.


How to be a Clinical Auditor


‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

Benchmarking Data


Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

Is your QMS compliant?


Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

ICH (E6) R2 Addendum - Step 4


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