The MHRA, EMA and FDA GCP Inspectors have reviewed and commented on the TMF Reference Model. The principle of the TMF Reference Model has been incorporated into the MHRA Grey guide chapter 10 and the EMA reflection paper.
The organisation of a sponsor file can become quite complex, especially when the trial is multinational or multi-centre. Typically documentation is organised in the sponsor file at three levels. This approach is recommended as it allows particular sections of the TMF to be made available upon request, although amalgamation of the files may be a more suitable approach if, for example, a single-country trial is being performed (with combination of global and country-level files) or when running a single-site trial, where all three levels can be combined.
The OASIS eTMF Standard does not accommodate artifacts (preferred terms) at these 3 levels, there is no country level. From my vast TMF experience, I know that not having a country level place to file does not work. It makes the eTMF unwieldy and difficult to navigate. In addition, many items can be at trial, country or site level e.g. protocol amendment. This cannot be accommodated in the OASIS model.
Karen
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