The TMF Reference Model has been developed to be equally applicable to clinical trials using investigational medicinal product (IMP) and those using medical devices and diagnostics (MD&D). The model includes metadata to designate certain artifacts as corresponding to IMP trials or to device trials. However, in practice, it is sometimes difficult to apply the model to MD&D trials. The terminology used for artifacts or the language used to describe the definition and purpose of an artifact is often too heavily slanted towards IMP trials. For example, zone 6 for MD&D trials should correspond to the test device or test diagnostic article but this is not self-evident in the way the model is worded.
It is for these reasons that we have initiated a new sub-team within the TMF Reference Model Project to identify how the model might be improved for use on MD&D trials. This might include, for example, enhancing the definition and purpose for existing artifacts so that the text is more meaningful for those trials. It might include the additional of sub-artifacts that are specific to MD&D trials. It might even include the additional of new artifacts!
If you have experience of MD&D trials and would like to participate in this activity, please apply NOW to join the group…. or encourage a knowledgeable colleague to join! It is hoped that this will be a fairly short-term project with deliverables expected in Q1 2018. Please only apply to join if you can spare the time to contribute; the output will be freely available to everyone. To join, please send a request to devices+subscribe@tmfrefmodel.groups.io, stating who you are and your company.