Your electronic Trial Master File (eTMF) plays a critical role in life-changing research. As the single source of truth for your clinical study, the eTMF must keep your data compliant and secure. In this blog, we look at telltale signs you need to update to a new eTMF system.
As a content management system, the Trial Master File (TMF) system stores and organizes the documents and data resulting from running a clinical trial. A critical responsibility is keeping this information secure and compliant, in alignment with global regulations.
So not just any eTMF repository will cut it. Just because you use some form of electronic storage, it doesn’t mean your TMF is manageable and inspection-ready. If any of these scenarios are relevant to your business, it’s time to consider moving to a new eTMF system.
3 Signs You Need to Move to a New eTMF System
Sign 1: Multiple Studies Use a Paper TMF
Although it’s less common for a company to use paper TMFs, it remains reasonable in some situations. However, paper TMFs make it difficult to assure Inspection Readiness, share documents across groups, and mine the value of the collected data and documents.
As the number of stored paper documents increases, the task of assuring Inspection Readiness can easily become overwhelming, which increases the value of an eTMF dramatically. If you are utilizing a paper TMF for multiple studies, it’s time to consider moving to an electronic version.
Sign 2: Your Electronic Files Are Scattered
There are two typical scenarios that scatter your electronic files: internally, your documents are housed in multiple, function-specific systems, and/or you have TMFs stored with different CROs.
When you store electronic files for a study across multiple, internal systems, it can be challenging to properly maintain compliance. Each system hosting your content must comply with the security, privacy, and retention standards for the eTMF. As a result, your TMF owner must influence processes and configurations across systems to assure compliance. If the document management standards are not sufficient for a compliant TMF, consider consolidation to a new eTMF.
In addition, you may need to access documents from these different functional systems during an inspection. This can present a problem.
Many inspectors request direct access, using the system’s user interface. Depending on the filing model and security for each system, this may expose data and documents beyond those included in the scope of the inspection.
If direct access is problematic or document management standards across systems are insufficient, the solution may be a more consolidated eTMF document repository.
Another challenge is TMF document sets hosted by multiple CROs or third-party vendors. Managing multiple filing standards and reporting systems may be cumbersome and confusing. Although systems are likely based on the TMF Reference Model, each organization typically has its own filing guidance and extensions to the TMF Reference Model.
Having multiple filing approaches for your documents invites error, adds further strain to your staff, and decreases efficiency. To reduce the complexity, consider starting with a central eTMF to create a consistent platform. It’s the first step to streamlining operations, even if you are only starting with new studies.
Sign 3: You Struggled to Answer Questions During a Review
During an audit or an inspection, you risk delays in securing answers, or worse, in finding documents if you have a paper or fragmented eTMF document set. In many cases, your struggle to answer will result in some type of finding. Although minor findings are potentially manageable, issues that persist across audits or inspections evolve into higher priority findings.
Consider an eTMF designed to sufficiently consolidate your document management and address current inspection needs if you need to address a finding or need better control of your document set.
It’s important to know when it’s time to move to a new eTMF system. For example, if you are using a paper TMF for more than one study, your electronic files are scattered, or you find yourself struggling to answer questions during a review, it’s time to make a change. One way to improve the odds of a successful move to a new eTMF system is to hire a clinical consultant who has the necessary hands-on experience.
Daelight Solutions partners with pharmaceutical, biotech and medical device companies to optimize RIM systems to streamline information gathering, organization and submission activities. Find out how we can help by contacting us today.