To comply with regulatory requirements, any organization that engages in clinical research is required to manage and maintain all clinical trial-related content, documents and data in a trial master file (TMF). In the current era of advanced technology and electronic mediums, clinical organizations have shifted toward maintaining all requisite content in an electronic TMF, or eTMF trial master file. The eTMF trial master file structure helps ensure that clinical investigations are conducted according to recognized standards of eTMF clinical trial compliance while also giving the organizations conducting trials an established means of providing conclusive evidence in support of product safety and efficacy claims.
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For compliance purposes, a TMF must contain all of the countless essential documents and artifacts pertaining to a clinical trial. The sheer volume of documentation makes it prohibitively difficult to manage a TMF using hybrid homegrown systems or paper files. An eTMF trial master file solution can ensure a TMF contains adequate and accurate data and that all information is maintained according to applicable regulatory compliance criteria such as Good Clinical Practice (GCP) standards. Data can be organized in eTMF trial master file systems in a manner that is suitable for evaluation by regulatory inspectors while also being readily accessible to internal and external clinical study team members.
The insurmountable difficulties inherent in using paper-based document management systems to handle what literally ends up being tons of TMF content are leading more and more organizations to switch to more efficient and robust eTMF trial master file software solutions. An electronic TMF management solution allows for a more streamlined approach to document management and provides the insight needed to conduct better clinical trials, ultimately accelerating a product’s time to market. A reliable eTMF solution is an invaluable process management tool that integrates eTMF trial master file-related processes with other core, compliance-critical quality functions.
An eTMF trial master file software solution can help standardize and streamline the essential activities of a clinical trial. Proven eTMF trial master file management solutions offer the ability to electronically manage the many complex interactions required by all study participants and contributors — such as sponsors, clinical research organizations (CROs), vendors and study sites — in an organized and secure manner that facilitates the completeness, compliance and audit-readiness of the eTMF trial master file. Robust eTMF solutions can also be useful in providing real-time updates as artifacts, activities and milestones are completed or altered. Such functionality can be useful in providing both granular snapshots of particular TMF components and a high-level status overview of the entire TMF.
One of the greatest challenges of eTMF trial master file management is dealing with the many inconsistencies that arise as a result of document creators employing a variety of document templates when eTMF documents are authored. Purpose-built eTMF solutions can help avoid these types of problems by establishing eTMF template consistency. A useful feature found in select eTMF solutions is functionality that allows document types to be configured so that only applicable document templates — a protocol template, for instance — are available for users to select from when they create new documents. This capability helps eliminate eTMF template discrepancies within the clinical enterprise and increases overall efficiency in eTMF trial master file management.
Whether your organization uses a paper-based or electronic system for TMF management, visualizing the basic framework of an eTMF template can be a useful starting point. You can get a copy of a helpful eTMF template that can be used as a blueprint for your own eTMF trial master file structure by downloading MasterControl’s free TMF Checklist Template. The complimentary MasterControl TMF Checklist Template is an Excel spreadsheet designed by a member of the Drug Information Association (DIA) TMF Working Group. Based on version 3 of the globally recognized DIA TMF Reference Model, it was developed to facilitate the management and collection of eTMF trial master file documentation from study initiation to study closeout. It is a helpful aid for clinical organizations that have not yet invested in an eTMF solution or those that are looking to supplement their paper TMF processes.
To meet the needs of a technologically flourishing clinical environment, MasterControl offers an eTMF trial master file structure that is specifically designed to enable real-time visibility into the status of all eTMF activities. With a design centered on the industry standard TMF Reference Model, the MasterControl Clinical Excellence™ solution provides for the efficient management of all documents, tasks, milestones and activities (such as monitoring visits and audits) that are required during the course of a clinical trial — all on a single platform. It also allows both sponsors and CROs to track the progress of pending, ongoing and completed eTMF-related actions. MasterControl’s cloud-based eTMF management solution is harmonized to be interoperable with the MasterControl TMF Reference Model JumpStart™, an out-of-the-box document management preconfiguration designed in accordance with TMF Reference Model best practices.
The MasterControl Clinical Excellence suite provides:
After deploying MasterControl Clinical Excellence solutions, organizations that conduct clinical trials are finding they are able to decrease implementation times and more easily stay within the boundaries of the standard electronic TMF management configuration recognized by global regulatory agencies. Furthermore, approved mobile and external light users are finding that they can access a centralized system to obtain information that is vital to their roles (i.e., as monitors, auditors or investigators) faster with MasterControl. Accelerating the flow of eTMF-related information with MasterControl eliminates bottlenecks and helps streamline the execution of tasks, which ultimately reduces the cycles times of critical activities associated with the eTMF trial master file, such as reviews, approvals and training.