How a Modern eTMF Ensures Inspection Readiness
Effective Trial Master File (TMF) management is crucial for regulatory compliance in clinical trials. An audit can happen at any time, so sponsors and CROs must ensure that all required documents are accurate and accounted for throughout the lifecycle of a study.
Ongoing inspection readiness is easier said than done, which is why many organizations leverage an eTMF solution to help. But there are a lot of eTMFs out there, and evaluating your options can be overwhelming. In this blog post, we’ve laid out key issues that a modern eTMF should address to improve TMF management and facilitate regulatory compliance.
Visibility
Before an organization can improve their processes in pursuit of better inspection readiness, they must be able to ascertain their current performance. Emerging or early stage life science companies may not have firm processes around TMF management, and therefore have poor insight into the state of their TMF at any given time: what documents do we need, and how many of those documents are accounted for right now?
An effective eTMF solution should be able to answer those questions at a glance through use of standard reference models and completeness metrics.
Automation
Without an eTMF solution, a sponsor organization will often find that document contributors are not getting their content filed in a timely manner. This often is because existing processes are intensively manual or complex, resulting in document contributors deferring the activity of formally filing the document.
The less work an individual has to do in order to file a document, the easier the activity becomes. That’s why a good eTMF solution should make it super simple to add documents to the system. Ideally there should be multiple options for adding a document, including uploading it directly to the system, importing it from a different system, or even sending it via email.
Document Quality
A TMF with low quality may have improperly scanned documents, documents filed to the wrong artifact, and other issues which may result in a regulatory finding. A modern eTMF solution should provide the tools for an organization to clearly define and adhere to a document QCing process that will allow reviewers to identify these mistakes and assign them for remediation.
An organization may want to QC only a representative sampling of their TMF. A great eTMF solution should support such a process.
Workflow
Given the complexity of TMF management and the number of individuals across multiple organizations involved, it can be difficult to understand what tasks need to be done when, and by whom. Without this information, activities fall between the cracks, and TMF completeness, quality, and timeliness suffer. Furthermore, without a clear and documented process, it can be hard to retrace what happened and identify responsibility when something does go wrong.
A modern eTMF solution should support formal workflows and task assignment for all of the key activities in TMF management, in addition to surfacing easily digestible metrics about how work is progressing throughout the study lifecycle. Each step along the way should be captured for traceability, leveraging features like version history, comments, and audit trail. Each user should have access to the features and content that they need, and nothing that they don’t.
Data Security
In the highly regulated world of life sciences, it’s extremely important to keep your users out of trouble by ensuring that their permissions are assigned properly. A modern eTMF should allow administrators to grant permissions to their users based on their needs, so that every user can accomplish what they need to, without having access to anything they shouldn’t.
In pursuit of minimizing configuration requirements, a poor eTMF solution may inadvertently make this problem worse by being overly prescriptive and providing a set of role-based, out-of-the-box security profiles. However, most life science companies have their own unique business processes and security requirements which are slightly different from everybody else’s; inevitably, those prescriptive security profiles would not align with their reality.
A modern eTMF solution should have configuration options that are granular and functional (like “Document Editor”), rather than role-based and tied to a job title that every company defines a little differently (like “TMF Manager”).
Archival
Archival is a problem often deferred for later, as it is the last step in the TMF management process. Leah Weitz, Senior Product Manager of Life Sciences at Egnyte, has seen how this frequently plays out: “The result is in an ‘uh oh’ moment near the end of the trial lifecycle, when an organization realizes that they don’t have a process or adequate system to support regulatory requirements as they relate to archival,” says Weitz. “They may find that their ‘archived’ content is not adequately protected from unauthorized access, that documents are not protected against changes, or that their existing process for archival is overly manual and therefore being deferred long past when it should have occurred. All of these are significant regulatory risks.”
As mentioned by Leah, a modern eTMF solution will have a simple, automated archival process. Once archived, content should be retained for as long as is necessary. Configurable security settings should allow the administrator to identify archivist users in accordance with regulatory guidance, and access to archived content should be restricted to those individuals.
Egnyte’s Modern eTMF
At Egnyte, we understand the challenges of managing clinical trial documentation and have developed an agile, automated, and secure eTMF solution laser focused on addressing them. Learn More about Egnyte's eTMF solution.
