Clinical research teams that use electronic Trial Master File (eTMF) systems rely on both useful technology and process management standards to drive efficiency along with compliance. However, not all eTMFs are created equally.
The factors that define a robust eTMF solution are: secure, role-based online access to all appropriate and required clinical TMF content in a database so you can search and retrieve documents effortlessly. It helps the trial and site staff to quickly find and fix any missing, duplicative or erroneous content; it also enables authorized users to apply electronic workflows for approvals, revisions, rejections, digital signatures, etc. At the highest standard, it lets well-paid professionals focus on truly value-added trial activities instead of duplicative, error prone check box drudgery. A good eTMF system combined with effective, quality-supportive process ensures continual inspection readiness and speeds trial completion.
When your eTMF is working well, users are able to share and easily retrieve information. Duplicate copies of documents are not floating around; all of the documents are correctly labeled and automatically organized. Clinical trials do not stall because of errors or administrative TMF mishaps, and expensive quality rescue efforts are not required to fill in eTMF gaps years after content should have been secured. When your eTMF is truly effective, the system is driving trial completion with actionable notifications (e.g. expiring docs, missing content) and automated process enablement (e.g. protocol amendment triggers, submission flow).
Here are some signs that your eTMF isn’t working for your organization:
The eTMF is an electronic graveyard. Older eTMFs are frequently nothing more than document repositories, without functionality to support the getting the trial completed. If your eTMF platform doesn’t enable clinical trial process, you’re not getting as much out of an eTMF as you could be.
No or restricted access. If access is restricted where it shouldn’t be, not all of the people that need to get to information can do so—so the system really is not an enablement hub for trial professionals. I have witnessed situations where sponsors that outsource to a CRO do not have the eTMF access level required and are needlessly exposed to significant quality oversight risks.
Team member inactivity. If a clinical team member isn’t using the solution, that means they do not see the need or have the desire to use the system. A TMF is crucial for marketing authorization approval. If all users are working on the trial, they all need to be involved with the flow of information, and accept their responsibilities as quality content stewards.
Information is mislabeled. When content is not properly classified and added to the internal taxonomy, it can cause expensive remonitoring or quality intervention. Administrative eTMF errors should be quickly exposed and corrected; if inspection readiness is not embedded in your eTMF, it’s time to rethink the system you’re using and the processes that support it.
In helping companies deploy functional eTMF systems, it is enlightening to see how much the right platform married to effective process helps. It not only makes working together easier and more cost-effective; clinical trial submissions never fall victim to an issue buried in the graveyard eTMF. It is clear when a life sciences company has a winning eTMF system because the system works for them, making it easier to manage the trial process flow, ensure submission and inspection readiness, and ultimately, drive product approval.
Connect with me on
Fran joined Paragon Solutions in April 2012, and is currently Associate Director in the Clinical and Regulatory Optimization practice. She previously worked at Genzyme / Sanofi for more than a decade, and has more than 20 years of academic and industry clinical and process expertise. She presents frequently at industry conferences, and is a member of several industry initiatives, including TMF Reference Model, OASIS eTMF Interoperability, and ACRES.