In an effort to establish a standard for trial master file (TMF) content in clinical trials, the Drug Information Association (DIA) devised the DIA TMF Reference Model. The DIA TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. Although the DIA TMF Reference Model is not intended to be simply used “out of the box,” it can be adapted to either an electronic or paper TMF.
The DIA TMF Reference Model helps companies meet the “essential documents” compliance requirements that have been set forth by the International Conference on Harmonization (ICH). As specifically stated in ICH GCP Section 8, such documents are “those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.” Since the ICH GCP does not provide a comprehensive list of contents for the TMF, the DIA TMF Reference Model provides a generally accepted structure for TMF-related data, documents, artifacts, and activities. The DIA TMF Reference Model allows organizations to effectively compile the minimum list of essential documents that will serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements. While not actually a regulatory standard in and of itself, the DIA TMF Reference Model is reviewed by regulatory authorities for the benefit of gaining valuable compliance input and serves as an extension of the electronic document management (EDM) Reference Model.
The intended audience of the DIA TMF Reference Model includes biopharmaceutical and medical device companies, contract research organizations (CROs), vendors, and other parties involved in the management of study-specific TMFs. Investigators who manage investigator site files or conduct investigator initiated studies also find the DIA TMF Reference Model useful. A 2015 survey conducted by DIA indicates that 85 percent of eligible respondents either currently use the DIA TMF Reference Model, are in the process of implementing the trial master file reference model, or are considering using the model.
The most recent release of the DIA TMF Reference Model, version three, was released by the TMF Working Group in June 2015. The DIA TMF Reference Model project team is comprised of more than 500 individuals from over 280 different organization and representing 30 different countries. More information about the group and the DIA TMF Reference Model and its function can be found on the DIA TMF Reference Model website or in the DIA TMF Reference Model user guide .
MasterControl’s eTMF Manager™ is an electronic trial master file management solution that is specifically designed to enable real-time visibility into the status of all TMF activities pertaining to a clinical study. Based on the industry standard DIA TMF Reference Model, the eTMF Manager provides for the management of all documents, tasks, milestones, and activities (such as monitoring visits and audits) that are required during the course of a clinical trial. It also allows both sponsors and CROs to track the progress of pending, ongoing, and completed trial master file reference model-related actions. The eTMF Manager works in conjunction with the MasterControl DIA TMF Reference Model JumpStart, an out-of-the-box, document management preconfiguration built to fit the Trial Master File Reference Model standardization.
MasterControl’s DIA TMF Reference Model-based software solution provides:
An eTMF-structured checklist template that is designed in alignment with the DIA TMF Reference Model
An integrated, out-of-the-box document management configuration of TMF document types, templates, metadata, version control, lifecycle management, routes, and user roles for all electronic trial master file artifacts
A secure collaboration environment for sharing and exchanging Trial Master File Reference Model content with internal and external contributors (i.e., sponsors, CROs, study sites, etc.)
A user-friendly “project plan” view of all Trial Master File Reference Model artifacts and related actions that ensures transparency and visibility into the status of all eTMF activities
Automated notifications of all TMF-related milestones and task assignments via email to assignees, including those external to the organization
Easy-to-use bulk importing/exporting functionality that facilitates a smooth, simplified transfer of electronic Trial Master File Reference Model documentation at study closeout
By using MasterControl’s eTMF Manager, clinical organizations are finding that they are able to decrease implementation times and more easily stay within the boundaries of the standard electronic Trial Master File Reference Model configuration recognized by global regulatory agencies. Mobile and external light users can access MasterControl to quickly obtain information that is critical to their roles (i.e., as monitors, auditors, or investigators). This enhances the flow of Trial Master File Reference Model information and streamlines the execution of tasks, which ultimately reduces the cycles times of crucial activities associated with the DIA TMF Reference Model, such as reviews, approvals, and training.
Select all the resources you’re interested in downloading