News

PRESS RELEASE – March, 2015 What’s coming in 3.0? Building on the most widely leveraged standardized reference in TMF management today, with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors, the next major release of the TMF Reference Model will incorporate feedback from its extensive industry use to […]

At the TMF Reference Model Project team meeting today (Nov 17), the review period to prepare for v3 of the Reference Model was formally opened. All interested parties – whether members of the Reference Model Project or not – are encouraged to provide feedback on their use of v2.0 of the TMF Reference Model. A

As previously mentioned here, the formal review process to develop the next revision of the TMF Reference Model is about to kick-off. To support this process, the TMF Reference Model Steering Committee has released a slide deck to provide an overview of the process and what is needed to make the review successful. The development

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

As you probably know, the draft eTMF Standard Specification is currently on a 45-day public review cycle. This review window closes on Friday 8th August. We have been asked by a few people to provide concrete examples of feedback that can be provided. As an example, the vocabulary taxonomy being proposed by the OASIS eTMF Technical

We’ve been alerted to the fact that some TMF Reference Model team members who have moved across to the new Yahoo! Groups collaboration platform may not be receiving emails and other notifications from the group. This is because Yahoo! creates a Yahoo! email address when a new user establishes a Yahoo! account (e.g. johndoe@yahoo.com) and by

The TMF Reference Model Project has grown from a small group of DIA members in 2009 to a team of well over 300 people today from around the globe, covering pharmaceutical companies, biotechnology companies, CROs, vendors, consultants and other interested parties. We have been struggling a little to keep on top of the list of

The TMF Reference Model Project have initiated a program to reach out to the eTMF vendor community to get input into a key subject which is generating a lot of discussion at the moment – eTMF interoperability. There was some initial work done on interoperability within the reference model subcommittees and more recently we have seen the launch

Please join the fourth industry-wide Trial Master File survey!  Make sure your perspective is heard, and get valuable insights and data for your TMF improvement initiatives.  An outgrowth of the volunteer TMF Reference Model initiative, this survey is designed to provide year-over-year TMF details from sponsors, CROs, inspectors, and sites, for both paper and electronic