What You Can Do to Drive Collaboration Across your TMF

This is part two in a series about how collaboration can impact TMF quality and inspection readiness.

In my previous blog, I spoke about why collaboration should be a key focus for organizations that want to up their TMF quality and inspection game. In this entry, I will discuss what organizations can do to foster a culture of collaboration and how it can impact TMF processes for the better.

The Guiding Principles for Collaboration
I’ve put together five key principles that should be foundational pillars as you build a more collaborative culture around your TMF.

1. Start with the finish line in mind. Have a clear target for where you want to be at the end of this effort. How should people be viewing their role in maintaining the TMF? What areas are currently weak that you want to strengthen? Understanding and owning up to current weak areas will help create more specific and achievable goals from the outset.
2. Gather all relevant parties and build a team mentality. When planning, make sure you have a broad base that includes the sponsor team, the CRO, and other service providers if applicable. Consider including data managers, and other study team members.
   Beliefs like, “This is my silo. That is your silo. I only care about me,” can be devastating to collaboration efforts. Buy-in is essential so that all relevant parties can establish the goals and understand their part in achieving them.
3. Create a specific plan for success. Start thinking holistically about what operating model you can align to. It might be an SOP, it might be a work construction, it might be the TMF plan, but a concrete plan will give your intentions weight and purpose that people can follow and uphold.
   Confirm the study team understands and acknowledges their role in contributing to TMF quality.
4. Empower individuals. Allow employees to execute the defined processes as part of the plan to the finish line. Ensure they’ve received adequate training, have the right tools, and have sufficient time to do what they are expected to do.
   Sometimes, extended teams are treated like suppliers rather than collaborators on the TMF. Instead, have the people who are often kept outside of the TMF be more directly involved. Philosophically, people want to feel empowered, but tactically, the people who are closest to the content are best qualified to determine the quality of that content and fix any issues.
5. Monitor the execution of the plan. Put methods in place to collect and analyze data about your progress, and don’t be afraid to address the processes or collaborators involved in that process. This could include assigning a dedicated person to monitor TMF completeness and quality.

   For example, the monitor could help the study team fill any study content gaps to facilitate completeness. To ensure quality, the monitor should reinforce that the individual who owns the content is responsible for ensuring the content is accurate and inspection ready. Although more challenging to track, this distributed accountability can speed the process and ensure TMF quality.

The Importance of Oversight
The final component that spans over the entire process is oversight. The purpose of oversight is to identify when something isn’t tracking on target. Without proper oversight, small problems can expand into more significant issues. It could be that team members hadn’t been trained adequately, or that retraining is needed. It might be that current process expectations are unrealistic and need to be updated. As you evolve and learn, don’t be afraid to change processes that need to change. Oversight shouldn’t be viewed as a burden or as a taskmaster. It should be considered a collaborative partner with everyone else because, without them, all the collaborative efforts so far could end up being for naught.

In the third part of the series, I’ll talk about how existing technologies can support collaboration efforts for TMF quality and inspection readiness.

Watch this video to learn more about collaborating effectively to transform clinical trials.