A TMF That Works With You: Achieving TMF Process Sustainability

Sustainable TMF processes are stable, repeatable, and scalable. Unsustainable TMF processes are poorly defined, constantly changing, time consuming, and introduce compliance risk. They make the workday a challenge and are a constant obstacle to our TMF goals.

Nobody actively seeks to make a process unsustainable, of course, but achieving TMF process sustainability isn’t easy. Without the right planning, implementation, and maintenance, any process can quickly become a hurdle rather than an advantage. Achieving TMF process sustainability requires uniting disparate stakeholders, gaining full process understanding, and working through immense complexity, tight timelines, and pressing resource constraints. Despite all these challenges, TMF stakeholders everywhere can take control of their TMF processes by mastering three stages of TMF processes development: TMF process design, TMF processes implementation, and TMF process maintenance.

TMF Process Design

In the TMF process design phase, TMF stakeholders identify the purpose, scope, responsibilities, and procedures that will be part of a new TMF process. You’ve got a great idea for a new process, but can you bring all the right people together to perfect it?

Plan End to End: When designing a new TMF process, it’s tempting to focus solely on the purpose for its creation. But, no matter how important a new process or the problem it addresses, the downstream effects of the process must be considered. Does a process require training? Will a start-up process inadvertently impact a close-out process? Does a new process impact SOPs or existing service agreements? All these questions must be considered in the process design phase and may require consulting non-TMF department SMEs from across an organization.

Remember the Real World: The process design phase is challenging for even the highest performing teams. Workshops and meetings to design TMF processes are time consuming and resource intensive. It is critical, therefore, that when stakeholders from non-TMF departments are asked to contribute to TMF process design, their time is used respectfully and efficiently by having a clear understanding of shared objectives before scheduling any face-to-face collaboration.

TMF Process Implementation

In the TMF process implementation phase, it’s time to put a process design into action as part of ongoing TMF operations. It’s time to act, but does your team have the tools to put the plan into action?

Execution Across the Lifecycle: Every TMF process needs to fit within the larger web of processes that comprise a clinical trial. These processes change as a clinical trial moves through its lifecycle. A new TMF process will likely apply across a department or organization that simultaneously operates multiple clinical trials. It’s critical that process owners consider how to consistently implement a new process at every phase of a clinical trial, especially high-intensity phases like study start-up, first patient first visit, last patient last visit, and close-out.

Integration is Essential: TMF professionals love the TMF. It’s their mission and the main focus of their day-to-day job. Other clinical trial stakeholders, for example monitors, coordinators, and clinical trial assistants, have different focuses. TMF process owners must consider the roles of everyone involved in a process and how a process will integrate into a role on the individual level as well as the organizational level.

TMF Process Maintenance

In the TMF process maintenance phase, existing TMF processes are updated to remain relevant among the constant evolution of business needs, tools, and regulatory expectations. Change is inevitable, but are your TMF processes flexible enough to adapt?

Nothing is Set in Stone: Even the best designed and implemented TMF processes needed to be updated occasionally. A successful TMF process needs to be designed and implemented with change in mind. This means prospectively creating a process for change control and management to support TMF processes. This TMF change control process should outline how the need for a change is identified, communicated, implemented, and tracked to completion.

Every Study is Unique: TMF process change is inevitable because every clinical trial is unique. A sustainable TMF process is one that is flexible enough to adapt to the idiosyncrasies of each trial. Stakeholders should know how to identify study specific documents and where to file them. TMF leaders should proactively identify process gaps or conflicts before start-up as part of procedure. These study-specific process changes should be logged and accessible to stakeholders, and these changes should be part of the training program for a study.

With so much to consider during TMF process development, there’s no wonder unsustainable TMF processes are one of the main causes of TMF negativity. Respect for both the challenge and potential that comes with TMF process development, however, keeps TMF process pain to a minimum and ensures TMF processes are sustainable for all. And when your TMF processes work with you, your TMF goals become one step closer to reality.