Drug Information Association (DIA) decided to develop a standard contents list for the TMF. The TMF Reference Model team was formed in 2009 within the Document and Records Management Community of the DIA. The first version of the TMF Reference Model (TMF RM)[5] was released in June 2010 and was updated in February, 2011 (v1.1) based on feedback provided by Regulators, and again in December, 2011 (v1.2), based on feedback provided by users of the model as they used it within their respective organizations to structure their paper and electronic TMFs. v2.0 in June 2012 and included expansions to the reference model. Artifacts, the term used for content types, were added for Investigator Site Files, Device trials, and Investigator Initiated Studies. The scope of metadata within the model was also extended in v2.0 to include the trial process with which each TMF artifact is associated. In June 2015 v3.0 of the TMF Reference Model was published. v3.0 includes provision for sub-classification of artifacts; identified as sub-artifacts. Section 01.03 (Trial Committees) was revised to provide additional flexibility, allowing for limitless numbers of committees to be managed within a TMF with a common classification structure. It also included 12 new artifacts, 8 removed artifacts and 1 re-classified artifact. The DIA states on their website 'The TMF Reference Model provides an opportunity for standardization across the industry, and can be used by any company in an electronic or paper format'.[5] Whilst the DIA doesn't have a formal, public and open standards effort in place to develop a formal, published standard, the use of the Reference Model is helping industry to standardize on the content of the trial master file, on the nomenclature for trial master file artifacts and on the taxonomy used. For clarification purposes, there is no intention by the DIA or the members of the Reference Model Project for the TMF Reference Model to be considered a formal standard. In September 2013 non-profit CareLex initiated an eTMF standards initiative under the OASIS standards organization to develop a consistent, machine-readable content classification model for eTMFs.[8] Rationale for the creation of the TMF Reference Model This initiative did not receive industry support and is now effectively dismantled. The TMF contains the trial sponsor’s and participating investigators’ set of content which individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced. These documents serve