How the Trial Master File is Evolving (2021)
The Trial Master File (TMF) is one of the most critical elements of a clinical trial, in fact, it is one of the first items any regulatory agency requests. Yet, many organizations don’t place the same importance on the TMF as they do on patient recruitment or data management.
Unfortunately, the failure to prioritize the TMF can leave sponsors and clinical research organizations (CROs) to appear disorganized, delay clinical trial completion, and, in the worst cases, fail at bringing treatments to market.
The Next Phase podcast host Blake Adams sits down with Sholeh Ehdaivand to discuss the Trial Master Files (TMF) and its pivotal role in the future of real-time collaboration between clinical research sites and sponsors.
Sholeh, president and CEO of LMK Clinical Research Consulting, founded LMK eight years ago to provide Trial Master File (TMF) document management services and help organizations streamline clinical trials by optimizing their people and processes.
Listen to the entire episode to learn how the eTMF fast-tracked the COVID-19 vaccine, how the eTMF evolution will continue to affect trial timelines, and recommendations for emerging biotech’s considering an in-house eTMF.
Blake: What is the TMF and what role does it play in clinical research?
Sholeh: The Trial Master File, or TMF, is the documentation from the clinical trial. Everything is documented because that is the industry’s way to show regulatory agencies around the world, including the FDA, that we protected patient’s rights and safety and that the data from the trial is reliable. [The
Electronic version of a TMF is referred to as an eTMF.]
Historically, sponsors and CROs think of their content [documentation] as the eTMF, and sites think of their content [documentation] as the Investigator Site File (ISF or eISF for electronic). But I am here to tell you that, together, these two components are what make up the trial master file. Both are equally important when the FDA, or equivalent, comes to look at a clinical trial.
Blake: What does the eTMF look like in three to five years?
Sholeh: We are in different iterations of technology right now, and we are talking about a crawl-walk-run approach. We are still crawling, and that is okay. I think that’s good for us because we want to get it right before we start to walk.
First, organizations were just moving into electronic versions of the TMF and out of the paper world. We’re taking baby steps. Now weneed to continue taking steps, and the next step is digitizing paper into the eTMF. For example, me going online, filling out a form that automatically goes into the TMF OR the eTMF talking to the safety system, so I no longer have to download information from one system to another.
Having interconnected systems is where we are going. [For our walk stage,] I can see technologies reading data and automatically filing into the eTMF. Our run [stage] looks like eventually where all of these systems talk to each other, and we’ll have more automation. Our jobs in the TMF world will be different, and we will be able to do more high-level, critical-thinking work instead of uploading, downloading, and filing.
Blake: How do current TMF specialist roles evolve alongside technology?
Sholeh: Completeness, timeliness, and quality of the TMF is something that organizations still really struggle with. It is important for us, in the TMF world, to understand that our jobs are not going to go away.
We see this in data management. For instance, jobs didn’t go away but people had to learn how to be more critical thinkers, learn thetechnology, and make the technology work for them. The TMF world needs to get ready for this. We are training our people and our sub-industry of TMF specialists within clinical research to be ready for the next five years.
Yes, it will change. Yes, it will be a crawl-walk-run scenario, but we have to be ready for that. We’re not paper-pushers anymore. We will really truly [have to] understand the clinical trial, milestones, protocols, and events.
The TMF is a critical element for any clinical trial, or the “superstar” as Sholeh would say. As an expert in the field with almost a decade since founding LMK Research Consulting, Sholeh knows the ropes when it comes to the TMF and is a great predictor of what helps teams be successful when transitioning or optimizing TMF processes.
Technology is sweeping through clinical research and the people and processes will have to evolve with these changes.
Listen to the entire episode, “eTMF: The Future of Real-Time Collaboration,” to learn how the eTMF fast-tracked the COVID-19 vaccine, how the eTMF evolution will affect trial timelines, what you need to do to be successful with your TMF systems, and recommendations for emerging biotech’s considering an in-house eTMF.
You can also connect with Sholeh to learn more about LMK Consulting and TMF University, a training program to prepare research teams to become TMF managers, by sending an email to hello@lmkcrc.com.
