The Trial Master File (TMF) is one of the most important systems in clinical research. It plays a pivotal role in demonstrating your assertion that your clinical study was conducted in adherence to the protocol using the principles of Good Clinical Practice (GCP).
Considering how much of a trial’s success depends on the TMF, you’d think it would be the number one priority. Unfortunately, though, that isn’t always the case. Trials have so many moving parts, that it’s easy for the TMF to get pushed to the back burner, which can have dire consequences.
Instead of trying to correct things retrospectively, establish a proactive TMF strategy. Here are five suggestions to help you get started.
1) Build out the TMF from the very beginning of the trial. You wouldn’t build a house without a foundation, and you shouldn’t start a clinical trial without a TMF. By taking the time to gather all the essential documentation, you can illustrate your trial’s adherence to regulatory requirements, be in a constant state of “inspection readiness” and avoid potential fines or penalties.
There’s so much to keep track of, it’s good to have a Trial Master File Checklist on hand. MasterControl offers a downloadable Excel spreadsheet that can help streamline your efforts. Access your copy here.
2) Establish a plan with clear guidelines and expectations for team members. Drafting your “TMF Plan” is only the first step. During the trial, you need to regularly update it. Instead of just “hoping for the best,” take the time to define roles and processes for each of your team members. Everyone needs to be on the same page.
Unsure where to begin? Assign a specific duty to each member of your team. Set clear deadlines for submission of documents and hold weekly meetings to ensure nothing falls through the cracks.
3) Document EVERYTHING. Clinical trials occur over a series of weeks, months, or years. During that time, various activities take place. Though it might seem time-consuming and tedious, it’s imperative you record everything.
If the trial ends and you don’t have the data and “essential documents” to back up your claims, it’s back to the drawing board. Likewise, if regulatory authorities conduct an audit (or even a “surprise inspection”) and you haven’t tracked your work, it’s sure to open a can of worms.
4) Establish a company culture that stresses the importance of the TMF. Unless it’s your job to meet with regulators, the TMF can seem like an abstract concept.
Not everyone on your team needs to be a TMF expert, but they should at least have a basic understanding of its impact on the study. When your clinical study teams feel like they have a stake in the health of the TMF, they’re more likely to pay attention and participate.
5) Consider subcontracting with a Functional Service Provider (FSP). Maintaining a Trial Master File is a lot of work. So much so, that you might find yourself spending more and more time sorting and filing paperwork. Instead of working longer hours, consider partnering with an FSP, like Harbor Clinical.
Our approach uses a Functionally Aligned Strategic Team (FAST™). The FAST is a group of subject matter experts (SMEs) who can complement your clinical trial at exactly the right timing and resource levels. We are prepared to implement, manage, and maintain your TMF.
Learn more about working with an FSP
We hope you’ve found these 5 best practices for maintaining a Trial Master File helpful. While it isn’t comprehensive, it provides some guidance on where to begin.
If you’re interested in learning more about teaming up with a functional service provider, please get in touch. Click here to fill out an online contact form or book a Strategy Session with one of our TMF experts at this calendar link: https://meetings.hubspot.com/harborclinical/meeting.