Building a strong TMF that is reliable, credible, and inspection ready at all times is crucial for the reconstruction of any clinical trial. Successful TMF trial management can be facilitated by:
- Standardizing Processes: Implementing SOP’s for filing or QCing a TMF document ensures your team is consistently delivering the same quality of work. An SOP is a useful tool as it increases company consistency, reduces errors, and improves communication.
- Implementing a Document List/Table of Contents: Filing documents into the TMF and differentiating one document type from another can be a tricky task. Implementing a table of contents for document submitters to rely on will reduce filing confusion and increase consistency.
- Monitoring Your Metrics and Controls: Metrics drive behavior and allow an organization to address any gaps in their TMF process. There is nothing more motivating than seeing your study “in the green” or “in the red.” By having a clear understanding of your study metrics, you will be able to better manage your TMF and improve inspection readiness.
- Organizing Your TMF Resources: From small biotechnology companies to large pharma/CROs, your TMF process will not be successful without the proper resources and TMF organization in place. Having people with the right background and training is essential to building a strong TMF.
- Utilizing an eTMF: The use of a sustainable, multifunctional, user-friendly, and of course, 21 part 11CFR compliant electronic system is crucial to your TMF health. Electronic repositories are not only providing immediate access to documents, but they also decrease time and increase the accuracy of the final study delivery, which can facilitate regulatory approval.
At the end of the day, a well-constructed TMF is proof that patients’ rights and safety are protected, which in turn will provide life-saving treatments to those in need. Do you need help establishing or refining your TMF process to ensure inspection readiness through your TMF continuum? Contact us today and see how we can help!