Traditional trial master file (TMF) systems offered little in the way of configurability or customization.
Often, the most flexible aspect of a paper-based TMF is the three-ring binder, which allows documents to be collected and stored in various ways. Other aspects of the TMF, including access controls, remained fixed.
Today’s electronic TMF (eTMF) options offer much more flexibility without compromising security. A configurable and customizable eTMF lends itself to better information control during a clinical trial while also boosting security and regulatory compliance efforts.
Improve Security Without Sacrificing Collaboration
The top challenges facing healthcare data management systems today all focus on data. Data transparency, interoperability, security, and provenance are key concerns.
In a clinical trial, TMF management must balance diverse access needs with regulatory and ethical requirements for privacy and security. The best eTMF solutions offer configurability and customization controls to strike this balance.
Role-based permissions customize access to eTMF documents according to each user’s role. Permissions are assigned to roles, not to individual users. This flexibility allows system administrators to see at a glance who has access to which documents.
Administrators can also control whether any role can edit a document or merely view it. If a user needs different permissions, their role can be updated easily.
Which TMF-related tasks have been completed? Which documents have information gaps? What tasks remain? Which items are overdue?
In a paper-based TMF, tracking this information requires dedication to recordkeeping in a separate set of documents.
In an eTMF, real-time dashboards can be customized to show exactly the performance indicators and timelines users need. Dashboards provide an at-a-glance overview of work status and each user’s participation in that work.
Paper-based TMF systems don’t adapt to the needs of users, even in the learning stage. Rather, users face the steep learning curve of adapting their own approach to the demands of the TMF.
An eTMF allows for faster, more complete implementation through configurability. Customizable software gives users an early sense of control and competence. Role-based access and similar tools reduce the amount of noise users must filter out before focusing on the tasks and documents that are relevant to them.
The bottom line: Customizable, configurable eTMF platforms make it easier for clinical trial team members to do better work, analyze data more effectively, and produce higher-quality results.
Meet Compliance Demands Easily
Many of the features that allow eTMF administrators to balance collaboration and security demands also help ensure that the clinical trial can meet regulatory and compliance demands.
Role-based access, for example, helps answer common questions from regulators, auditors, and investors, including:
- Who accessed which documents in the eTMF and when?
- What changes did each person make, if any?
- How do you control access to documents so that only authorized users see them?
The Verizon 2021 Data Breach Investigations Report estimates that 61 percent of data breaches originate from compromised credentials. Role-based access helps limit these data breaches by limiting access through any one set of credentials. Even if a hacker gains access to a team member’s login information, they can access only what that team member is allowed to view.
Configurability and customization options in an eTMF also help clinical trial teams meet ALCOA-C requirements:
Paper-based TMFs regularly resulted in ALCOA-C related lapses. In Perspectives in Clinical Research, Chitra Bargaje estimates that 60 percent of FDA warning letters included a warning that one or more ALCOA-C elements were violated. As configurable and customizable eTMF platforms become more commonly used in clinical trials, this number is decreasing.
Paper-based trial master file systems served their purpose — but they also pose difficulties in their lack of configurability or customization. An eTMF platform with robust configuration and customization options enhances security, helps teams meet regulatory demands, and boosts collaboration and data management options.
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