Trial master files are essential for the completion of clinical studies. However, the management of TMF content can be very complex. eTMF systems represent the next step in clinical trial document management and promise to become an integral part of all future clinical research.
What is an electronic trial master file (eTMF)?
An electronic trial master file (eTMF) is a digital upgrade to paper trial master files. An eTMF software solution can be used to receive guidance and assistance in the setup, collection, storage, tracking, and archiving of essential clinical study data.
eTMF solutions empower clinical teams to effortlessly create, upload, classify, and index data related to their research. Thanks to the software’s capacity to connect to the cloud, eTMF systems for clinical trials allow documents to be viewed and collaborated on from multiple locations in real-time.
What does an eTMF do?
Modern eTMF platforms reduce the cost, complexity, and time required to manage clinical trial processes. While the main function of eTMF systems is to digitalize clinical trial documentation, innovative eTMF solutions can also act as a hub for the different parties involved in clinical trials to seamlessly collaborate.
At its core, an eTMF system is built to manage clinical trial documents. eTMF platforms are able to automate most tasks that would otherwise require manual input. Likewise, the organization of documents and accuracy of processes are improved through the gathering of metadata. However, an electronic trial master file solution can offer much more than mere document management.
Electronic trial master file solutions are powerful software tools for collaboration. A modern eTMF provides CROs, sponsors, and clinical sites with the ability to cooperate and coordinate activties through the application. Users can author, review, edit, and approve documents without the need for any other software. Additionally, the eTMF software infrastructure offers a secure communication channel and an extra layer of transparency to the whole research process.
Why is an eTMF important?
Electronic trial master files have rapidly become the standard for big and small companies alike. The efficiency, convenience, and cost-effectiveness of eTMF solutions have converted them into the preferred choice of many life sciences companies and regulatory agencies.
Previously, eTMF software was a luxury only larger companies could afford. However, the latest generation of eTMF applications are easy to deploy and helps reduce operational costs. This allows small companies, even those without a dedicated IT department, to implement eTMF solutions without hurting their bottom line. On the contrary, an increase in operational efficiency directly correlates with improved profitability.
Factors that contribute to the popularity of eTMF software include:
- Modern eTMF systems allow for the global, real-time availability of clinical trial documents.
- Users enjoy an enhanced document management environment, including file management and document workflow solutions.
- An electronic trial master file solution keeps track of critical metadata. Thanks to this feature, documents can be sorted, categorized and grouped on any number of attributes.
- A clear audit trail is always maintained. This substantially simplifies the auditing process.
- eTMF functionality ensures regulatory compliance. Regulatory bodies such as the FDA and the EMA have released guidelines for the appropriate use of electronic clinical documents.
6 Benefits of an eTMF
1. Faster processes
One of the main benefits of eTMF software is a shortened clinical timeline. eTMF systems improve the speed of studies while also making sure every person involved in a study has access to the latest version of all available documentation. Additionally, the automated quality control of trial master file content allows for the progressive and continuous compilation of documents without the need to check for mistakes.
2. Simplify communication with IRBs/IECs
eTMF software streamlines collaborative procedures with institutional review boards (IRB) and independent ethics committees (IECs). The software can be used to create portals specific to IRB/IEC needs, where access to the specific documents they need can be granted and facilitated.
3. Reduce paper use
eTMF applications are an ideal solution for minimizing the use of paper in the workplace. Fewer paper documents mean less snail mail, scanning, filing and refiling, storing, and retrieving documents, as well as removing the costs related to those tasks.
Just like the computer and the automobile before it, an eTMF stopped being an optional, expensive “nice-to-have” and become a necessity. This is due to the software’s capacity to provide convenience while also increasing operational efficiency. For instance, repetitive tasks can be accomplished automatically by the software, freeing the hands of professionals to focus on more productive assignments.
5. Strengthen the collaboration with sites
Achieving TMF completeness while working with multiple site-level documents can be a very stressful task, but not when using an eTMF. From eliminating document overlap to simplifying the conversion of investigator site files (ISFs) to a TMF format, eTMF makes site-related tasks much easier for all parties. You can trust the application to always provide up-to-date and easily accessible documents.
6. Streamline collaboration with CROs
By keeping all TMF content in a single, central hub, an eTMF removes the stress of having to physically transfer paper documentation to the CRO. eTMF content can be accessed remotely from any location. The software offers many quality-of-life upgrades that allow CROs to fully understand and comment on documents without leaving their desk. Additionally, overhead costs associated with the shipment of documents become a thing of the past.
How is the eTMF evolving?
While eTMF applications were initially envisioned as a document-sharing application, it has become a system that allows for seamless document and process management. Furthermore, eTMF solutions help circumvent several issues related to clinical research.
In a day and age where the speed of processes has been made paramount, the latest generation of eTMF systems offer organizations the capacity to tackle challenges at a speed previously unattainable. From access to templates to automatic document updates, eTMF has become the fastest method of finding trial master files.
Interactions between sponsors, sites, and CROs are considerably enhanced by the collaborative features of modern eTMF. Likewise, the software has also evolved into a collaboration hub, where all the study stakeholders can share messages and information.
Common eTMF features
1. Real-time document management
With an eTMF system, one can track and view documents in real-time from the location of their choice. The software makes it possible to check on the status of eTMF documents to see if they are completed, filed, or missing. Accessibility tools such as reporting and data exportation tools further improve the document management capabilities of eTMF.
2. Indefinite reusability
All documentation created using an eTMF solution can be structured in a uniform manner. Users have access to templates that they can use to keep their work consistent, while automation guarantees all documents remain organized. Thanks to this, documents created for one study can easily be reused to support future research.
3. Easy remote collaboration and data collection
An eTMF solution works as the main hub for a study team to work together. The whole TMF process, from setup to archival, can be viewed by multiple professionals remotely, who can also comment on its various moving parts.
4. Improved document search and retrieval
An eTMF turns spending time looking for documents into a thing of the past. Clinical trial documents are created and uploaded directly to the system, together with metadata that makes them easier to locate, retrieve, and inspect. The software gives users tools to customize the way they want the organization of data to be handled. For instance, users can choose to organize documents using pre-defined TMF content structures. Search queries can be based on metadata or on content found in the document itself.
5. Easy progress tracking and coordination
By placing the functionality of several systems into one, eTMF helps users to coordinate processes with greater accuracy. Since the software always keeps the most up-to-date versions of all documents, there is no need to worry about anyone working with outdated information. In the same vein, all certified professionals have real-time access to information about how the study is progressing. And the aforementioned search and retrieval features ensure that documents will be readily available whenever a monitor needs to view them.
6. Enhanced key performance metrics visibility
eTMF software allows users to extract actionable insights, such as key business intelligence, directly from clinical documents stored in the system. In addition, the decision-making process can be guided by embedded analytics provided by the software.
Due to the sensitive nature of clinical research material, it is indispensable for eTMF solutions to have cutting-edge security features. Not only is eTMF software password-protected, but it is also capable of keeping critical information away from prying eyes thanks to robust system infrastructure. This makes it easier for those who should view documents to do so while making it harder for those who don’t.
8. Improved audit and inspection readiness
Since all documents are created and stored directly on the system, they are available and accessible to anyone with the right credentials. And modern eTMF systems have built-in workflows for quality review processes. This ensures that all documents have undergone formal quality control.
Regulatory bodies, such as the FDA, give digital signatures the same value as pen and ink signatures on paper documents. Taking advantage of this, eTMF solutions provide electronic signature technology to conveniently speed-up compliance procedures. eTMF solutions also work to the benefit of inspectors with specialized views and searching tools provide a filtered view that facilitates inspection. Moreover, the system’s reporting tools can indicate which documents will be needed prior to an inspection.
eTMF for clinical trials
Upgrade your clinical trial management capabilities with Agatha’s eTMF. Our innovative eTMF solution connects all trial participants and processes in a single, cloud-based environment. Agatha’s eTMF is user-friendly and easy to implement. By connecting sponsors, CROs and sites, everyone involved in a research project is able to operate Agatha’s eTMF with ease.