The efforts in managing and locating files are becoming tiresome for many clinical research organizations. Electronic Trial Master Files (eTMF) software is becoming necessary for managing clinical trial documentation replacing bulky files.
If you are in search of an eTMF, then you need to be aware of many aspects and features you need to look at.
What is a eTMF?
An eTMF or electronic master file is a Trial Master File in electronic format. It is a process of capturing, managing, sharing, and storing those essential documents and content electronically (digitally) from a clinical trial.
What are the basic functionalities does a eTMF does?
eTMF systems/software help to store electronic records or digital documents. The content is generally subject to the following requirements as
- digital content archiving,
- security and access controls,
- change controls,
- audit trails, and
- system validation.
All eTMF have basic functionalities but differ in their approach to digitizing and managing the TMF.
What are the key benefits of using eTMF?
- Saves cost by improving filing efficiency and reduces laborious paperwork.
- Quicker document searching and retrieval.
- Help to minimize trial start-up and close-out time timelines.
- Documents/reports can be audit-ready far quicker than paper systems and improve regulatory compliance.
- Allows easy access, approval, sharing and manage clinical documents anytime and anywhere from a web-based application.
- Reduces errors commonly seen in manual paper documentation.
After seeing the importance of eTMF now, the next step is to find the best eTMF software application for your clinical trial from hundreds of vendors. After reading this article, you may become an expert in choosing the best eTMF software. So let’s look at the points you need to consider while selecting the best eTMF for your clinical trial.
Top 10 features eTMF features you need to look at while choosing
Workflow of an eTMF
In the conventional process, you have a lot of document work to manage when monitors are performing site visits. By using the eTMF software, you can quickly upload the documents into eTMF and centralize the process. It saves more time for monitors to perform other value-added tasks such as risk-based Source Data Verification (SDV) and have a meeting with investigators on site. This de-centralized process also allows different users to collaborate. The eTMF must maintain the version history. As the version history is a part of the audit trail that inspectors will be able to access and view.
Design of eTMF
The whole data management will depend on the structure and design of the eTMF. It helps to store and determines how quickly you can retrieve the data. It also helps during audits and inspections where you may need to transfer data to eClinical systems.
Usually, eTMF are designed to manage multiple master files for numerous studies at a time. For this, you need multiple user access simultaneously and have the ability to define user roles. The system should have the ability to give access to the users based on their roles. In such case it retains privacy such that the user views only the information he is accessible to. You should be able to create both, roles and define the accessibility for each role.
Notifications & tracking
Notification to users is a must-have feature for the eTMF system as these automated notifications remind users about completing tasks, uploading documents, and alerting forthcoming tasks. Notification may be through emails, SMS, or app notifications. It also communicates between users to alert tasks in the system internally. These notifications should elaborate the task in detail about what users needs to do.
The paper-based documentation was more prone to errors and risk of discrepancies due to incomplete or missing documents. It was due to poor tracking. Now the electronic systems are helping to track missing or incomplete documentation and allow for follow-up. Milestone tracking is crucial for any clinical trial project and allows sponsors or CROs quickly identify discrepancies. These help stakeholders to reach the site and provide support and resolve issues.
TMF search, Archiving & Retrieval
The search feature looks simple, but technically, it depends on the database design and how your data is compartmented. The system shall show the relevant content based on the key search words. It defines how easy it is for your team to find and retrieve documents in your TMF.
The eTMF system must have comprehensive archiving and retrieval functionality. The user can access archive documents at all times. The eTMF system shall also have a centralized repository where all the final records are stored securely. The software vendor shall facilitate the document archiving for years. (25 years as per new European regulations).
Digital signatures show proof that the person had a chance to review the document before finalizing. The signature technology in eTMF shall meet 21 CFR Part 11 to show that clinical trial workflows comply with all the necessary regulations.
System integration & ISF Reconciliation
While using electronic systems for your clinical trials, you need to look into software integration capabilities. Very few vendors are actively providing integrations. Integration facilitates data exchange between systems and facilitates users.
Having eTMF that allows you to reconcile documents is a necessary feature in the eTMF. The system shall help complete the Trial Master File by integrating with your research sites’ eISFs. Integration of ISF with the eTMF helps CRAs to quickly identify missing, expired, or incomplete documents.
Apart from the above features, you need to always think about how easy the system to adapt, how much it costs, and what are services the vendor offers. By keeping all these points in mind, we have described a few systems available in the market below that meet all the basic requirements.
Top eTMF systems available in the market
TransPerfect provides the most practical, user-friendly TMF system and covers most user needs. TransPerfect eTMF is practical, secure, compliant for TMF documentation. It supports all essential document processes and reduces the time, costs, and risks of TMF management.
Oracle Health Sciences pioneer in the provision of Trial Master File (TMF) technology and services for the global life sciences industry. Oracle’s PhlexEview TMF management system uses automation to streamline processes, open architecture to ensure easy data integration, and provides advanced functionality designed to facilitate TMF Management.
Clinvigitlant’s eTMF is a powerful application that connects sponsors, CRO staff, and site resources with automated processes for creating, managing, and tracking the Trial Master File (TMF). Clinvigitlant’s eTMF allows users to gain real-time visibility into the status of all clinical activities. Based on the TMF Reference Model, the solution simplifies the management of all the documents, tasks, milestones, and activities required during a clinical trial. It makes your TMF inspection ready and connects with sites, CROs and sponsors.
SureETMF is a cloud-based regulatory content management application for electronic trial master file (eTMF) documents. SureETMF automates the capture, digital completion, signing, classification, and tagging of content via collaborative portals.
ACM’s Electronic TMF lets you ensure completion, compliance, and access to clinical Trial Master Files throughout the study lifecycle. It supports speed communication and collaboration for investigators and site staff. ACM Trial Exchange delivers portal access for clinical sites, so they can monitor tasks, view status, and submit documents with ease.
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