Explaining TMF to the 99%: An educator’s thoughts and musings on eTMF

October 2, 2013

  • eTMF Resources

In her recent article, eTMF for the 99%, Kathie Clark discussed some of the under-estimated considerations when planning eTMF systems. She highlighted some of the assumptions made about eTMF capabilities in the context of the wide variations in user skills and systems knowledge. Creating a role-based learning strategy is frequently overlooked or left to last in technology projects. In the transition to e-TMF failing to fully consider how your organization will educate a staggering amount of new internal users as well as contract organizations, vendors and external experts is a major risk. In an eTMF project organizations must delineate new system roles, plan oversight and metrics reporting and define the processes clearly as just some of the required tasks. Overlooking the development of a sustainable learning program can undermine even the best of intentions to implement an eTMF system. And eTMF systems must be able to deliver a complete, quality-driven, inspection-ready TMF. This is difficult to do when users are not entirely familiar with what TMF content is all about.

Often my first task as a system educator is to help users understand the TMF before we can comfortably reach an understanding of the eTMF. Prior to eTMF systems, users were shielded from the details of TMF management. Users may have sent their documents to a control center and were spared the complexities about how to index, verify the content and and decide where to store it. In an eTMF system, users are responsible for adding content and applying metadata and initiating workflows and need to be keenly aware of these control details. And even more importantly, they need to understand the bigger picture of why a quality TMF is critical for the sponsor organization. This is driving demand for learning and education; notice I didn’t refer to it as training! Training implies that we have operationalized the steps – the final chapter on eTMF remains to be written as industry endures another transition to a – dare we say – standardized eTMF?

TMF involved paper in the past – lots and lots of paper followed by lots and lots of scanning and filing. These tasks were typically confined to a group of knowledgeable document controllers who functioned in the “back room” using a mixed bag of file management and various systems to build the TMF and they were (and still are) excellent at it! These experts understood the content that came in and what needed to be done with the volumes of documents they received from internal staff as well as external contract organizations. As trials have grown in complexity and reliance on contract research organizations expands, trial master file content requires systems that are designed to manage vast collections of information coming from multiple sources. The document controllers no longer work alone; new systems are shifting the control and management of TMF content to a wide new audience of end users on a global scale.

A wide variety of disciplines now have new responsibilities to keep TMF content current, updated, complete and accurate. Oversight and management of TMF content has moved center-stage as well as reporting and metrics to senior level professionals. If you are still with me, you can begin to appreciate the impact of the eTMF transition. And I must stress that there are a variety of approaches to eTMF and a lack of one common standard for how eTMFs are constructed.

So the end user community has expanded, systems vary in how they deliver eTMF controls and we find ourselves without a single, comprehensive technical standard for how all of industry should be implementing eTMF. Multiple approaches to eTMF exist but in the eTMF system I am describing, a sponsor has one platform that requires all contributors to use. This means there are many new stakeholders who require education about the process, regulatory requirements and lastly, the technology itself. And I would be remiss to fail to mention that a critical user role is that of a health authority inspector. As some authorities are conducting hands-on system inspections, this introduces another level of complexity and need for rapid advancement in how eTMF systems can present the information. Inspectors will not tolerate intensive learning sessions or cumbersome technology so that they can get their jobs done. A comprehensive learning program must consider this scenario as well way before an inspection occurs.

I hope I have in a summary fashion underscored why education in this new eTMF world is critical. The investment in eTMF systems is substantial and reflecting back upon some industry history with document management systems, as one example, industry can no longer afford major system failures because we are not willing to accept that the 99% caught in this major transition to e-TMF require education. The stakes have increased and the consequences of not educating end users have yet to be felt. So I leave you to reflect on this —–where is your educational strategy and plan for your eTMF transition?

Good luck and continued good learning. – N. Celini

 

Nancie CeliniThis post was written by Dr. Nancie Celini,  an educator, health information technologist and health technology researcher guiding the bio/pharmaceutical industry in the implementation of document management, electronic trial master file (eTMF) and e-learning platforms. She educates a global audience of clinical research, public health and medical professionals. As a seasoned instructional designer and professor, she has developed courses for The New York Times Knowledge Network on healthcare reform and New York Medical College where she received a Master of Public Health and Doctorate of Health Policy. She is one of the original authors of the Electronic Document Management (EDM) Reference Model that led to development of the Trial Master File (TMF) Reference Model. Her passions include health, technology, research, fitness and lifelong learning.

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