What’s Happening with the TMF Reference Model?

You may be wondering what the connection is between the  TMF Reference Model and the Drug Information Association (DIA) and how the Reference Model is managed. The information posted below should help to provide some clarification.

Has the DIA dropped the TMF Reference Model?
No. Following a discussion towards the end of 2012 about the official name for the Reference Model, it was mutually agreed that the term “DIA” should be omitted from the name of the model because the intellectual property rights are not owned by the DIA. The model itself was developed by a large community of industry colleagues, the vast majority of whom were and still are DIA members. However, the model is in the public domain and owned by industry as a whole, so for this reason it cannot be referred to as the “DIA” TMF Reference Model. The DIA have not “dropped” the Reference Model or discontinued any association with the model or the group of colleagues that are part of the TMF Reference Model community.

Has the DIA selected the OASIS eTMF Standard as the preferred standard, rather than the TMF Reference Model?
No. The OASIS standard should be viewed as a technical standard to facilitate exchange of documents, whereas the widely accepted TMF Reference Model is setting the content standard, (e.g. attributes, vocabularies, classification and artifacts etc.). Within the context of the proposed OASIS classification scheme this means that the OASIS-proposed CareLex model is an example of an ”organization specific content type or category” whereas the TMF Reference Model must be the domain specific base model. The DIA have NOT gone on record to support the OASIS eTMF standard, though they were asked to do so.

Has the DIA dropped support for the TMF Reference Model community?
No. The TMF Reference Model is still an active DIA group and exists on the DIA Connex site as part of the Records and Document Management Community. However, because involvement in the group’s activities is not exclusively restricted to DIA members, a decision was taken recently by the TMF Reference Model Steering Committee to use a public collaboration platform (Yahoo! Groups) to communicate with members of the group. All recent documentation pertaining to the group is available in a transparent manner to members via this route. We also use other tools – such as this website and LinkedIn – to communicate to the industry as a whole. The group is still very much affiliated with the DIA. The vast majority of its members are also DIA members but just as the DIA permit non-members to attend DIA conferences and other DIA events, we permit non-DIA members to contribute to the TMF Reference Model as we do not wish DIA membership to be a hindrance to broad industry input.

Does the TMF Reference Model Group have elected leaders and official records?
Yes. Towards the end of 2013, it was proposed that a Steering Committee be formed to help guide the group. An initial group of members was proposed for the Steering Committee comprising primarily of the Zone Leads. Following a communication to the whole group in December 2013, a small number of additional members came forward to join the inaugural Steering Committee to make a group of fourteen. The list of Committee Members and their Charter are available for any member to see on the group’s Yahoo! site. A formal ballot was held to elect Chair, Deputy Chair and Secretary by anonymous, electronic voting. The results of this ballot are on record. The current holder of these three positions are Karen Roy, Steven Scribner and Eldin Rammell. In accordance with the rules of the Charter, as membership on the Steering Committee expires, the vacant positions will be opened up to nomination from any TMF Reference Model member. All records of the Steering Committee and TMF Reference Model team are filed on the Yahoo! site.

So the bottom line is, the TMF Reference Model is still very much alive, is associated with DIA as part of the Records & Document Management Community and is developing exciting plans for the rest of 2014. Keep a watch out for the roadmap…. this will detail plans for the various activities that we aim to undertake over 2014 and 2015!

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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