At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release. The reference model is not mandatory, but it is gaining wide acceptance in the industry. And the working group made clear from the outset that this effort is purely about standardization. It does not endorse any technology or application, and the model can be applied equally well to an electronic or paper-based TMF.
Nevertheless, many trial sponsors are considering eTMF solutions for the same reasons that organizations eschew paper-based information management in other domains. Well designed digital document management can be cheaper, faster, more secure, and more accessible, as well as easier to automate. Although no standard exists for eTMF offerings, EMC believes that a sensible approach to eTMF solution design rests on the TMF reference model.