to demonstrate compliance with the standards of GCP and with all applicable regulatory requirements.[1] It is part of the evidence provided for regulatory inspection that verifies that the members of the trial team: ensured subject protection, compliance with regulations/Good Clinical Practice, and that scientifically robust benefit-risk data was produced. While ICH GCP E6 details the minimum essential documents, it addresses only a sub-set of TMF content that is required to be created and available for inspection. Documentation requirements for the set-up and maintenance of quality systems, electronic systems, safety monitoring, and proof of an adequate and well-controlled trial, to name a few, exist in various regulations across many countries or regions, but are not explicitly described in ICH GCP E6. Since there was no comprehensive, common industry model or best practice for a TMF, the objective of the TMF RM is to provide a single, unified interpretation of the regulations of the ICH regions as a document-type listing which would be accepted by all clinical trial stakeholders and which can be adopted or adapted by any company, institution or organization. It does not provide guidance on the process by which the content is created, managed or retained. TMF Reference Model shortcomings As of May 2013, the TMF RM v2.0 was made available in an electronic spreadsheet format which is suitable for human viewing. While the TMF RM is acceptable for paper TMFs, there is no support for TMF content exchange between computer systems. As the TMF RM is not a standard and is therefore not fixed, the TMF Model allows for flexibility in approach and any aspect of the model can be changed to suit an individual user's needs. Whilst this benefits the individual user, it results in variances in use and interpretation from one company to another. One issue with the use of the TMF RM as an eTMF classification model relates to duplicate artifact names in the TMF RM. The current release of the TMF RM v3.0 contains several duplicate artifact names such as 'Communications' or 'General', each with different contexts and uses but the same name, which makes the TMF artifact names more challenging to implement in eTMF search and retrieval where a unique set of search results is desired.[9] A second issue with the TMF RM relates to the length of the TMF RM artifact names - one artifact name is more than 64 characters. Different