Successful trial master file (TMF) management requires constant and careful attention to each process, procedure, and guideline.
This ensures a TMF is completely up-to-date, compliant, and ready for inspection at a moment’s notice.
You know that maintaining high TMF quality is critical for the study. But how can your team stay on top of both daily rigorous TMF tasks and all the other moving parts?
Here’s how a TMF study owner can fill your resource gaps to ensure your TMF is always inspection ready.
TMF Study Owners
TMF study owners are highly experienced, flexible TMF resources who act as an extension of your clinical study team. Their main goal is to provide the support you need to maintain ongoing TMF health and inspection readiness.
This expert works closely with your study or TMF teams to support the implementation and refinement of your TMF processes, plans, and standard operating procedures (SOPs). They also create tools, such as story boards to show the history of a study. They provide analysis of key metrics and key performance indicators (KPIs) for completeness, quality, and timeliness. These tasks are important for identifying opportunities for improvement, optimizing current processes, and achieving successful audits and regulatory inspections.
The TMF study owner is very much a subject matter expert (SME). They provide training to internal teams on best practices and global regulatory standards. This ensures organizations are up-to-date with industry expectations, enhancing TMF culture within study teams.
Why You Need Them
The TMF is a source of evidence examined by regulators to ensure credible clinical trial data and protection of patients’ rights and safety. By having the right resources and expertise, you can eliminate potential roadblocks and bring life-saving treatments to market faster.
Having TMF study owners eliminate the burden of high internal TMF employee turnover. They also eliminate the challenges internal teams face when juggling multiple roles. TMF study owners act as dedicated TMF resources who provide stability throughout the life cycle of clinical studies. This provides consistency across clinical trials and programs, increases quality, and reduces the risk of non-compliance.
TMF study owners are trained to work with study teams to review important metrics, trends, and KPIs. This is something internal teams can find difficult to grasp. They can produce reports to identify missing and overdue documents, understand why documents are failing in QC, analyse whether documents are filed promptly, and provide recommendations for new processes. These skills help TMF study owners find and rectify issues that pose risks and lower TMF quality.
Many companies are looking to move their paper TMFs to electronic versions. This is great for enabling smarter, more efficient ways for study teams to work. However, this also brings challenges for internal teams. They must now invest time in training and understanding new roles, responsibilities, and configuration. TMF study owners adapt to using a variety of systems. They support implementations, prepare supporting procedural documents, and create RACI (Responsible, Accountable, Consulted, Informed) matrices. This minimizes the effort involved with migrating a TMF from paper to electronic.
TMF study owners are flexible and can integrate with study teams to play multiple roles. They can be a short-term solution for a particular project. This can include performing independent quality reviews or planning and executing major audits and inspections.
TMF study owners can also be long-term solutions to support multiple projects, from TMF setup and maintenance to study closeout.
Their scalability allows them to work globally with small biotechnology or large pharmaceutical companies, depending on an organization’s needs.
What Their Day-to-Day Looks Like
TMF study owners assist study teams with all activities related to TMF management. Tasks depend on the phase of the TMF life cycle and resource constraints within organizations.
At start up, TMF study owners support development of SOPs and TMF plans that define TMF expectations between sponsors and relevant stakeholders (e.g., CROs or vendors) to ensure delivery of a high-quality TMF. They also define what is expected from all concerned parties (CROs, vendors, and sponsors).
Additionally, study owners support TMF setup. This includes system management (user management, creating placeholders) and document list and storyboard creation. All of which help in mapping and organizing the TMF.
During maintenance, TMF study owners monitor metrics by running reports on completeness, quality, and timeliness. This helps them understand and report trends and address any gaps in the TMF process. They also collaborate with study teams to check on study milestones and process compliance. Additionally, they complete periodic quality reviews to ensure TMF completeness and inspection readiness.
TMF study owners can even help teams create and deliver training programs to build knowledge and awareness of good TMF and document management.
At study closeout, TMF study owners ensure all required documents are filed and prepared for archiving. Throughout this process, they confirm all closeout procedures are completed and prepare closeout summaries and checklists.
During inspections and audits, they provide pre-inspection reviews, lend support on questions, work with internal teams to analyze findings, and provide any necessary solutions.
A Final Case for TMF Study Owners
Amid the challenges of the COVID-19 pandemic, sponsors and CROs are adopting new technologies and smarter ways of working. By doing so, they’ll allow more efficient clinical trial and TMF management.
These organizations are also responding to increasingly complex expectations from regulators. This makes it even more critical to have skilled TMF professionals ensuring each clinical trial is fully compliant.
By collaborating with TMF study owners, organizations have that extra support from a specialist. This allows them to implement new systems successfully, strengthen processes, and deliver a high-quality, timely, and complete TMF.
To learn more about how Trial Interactive can help you support daily TMF management with a TMF study owner, contact us today.