Electronic Trial Master File (eTMF) in Clinical Trials

What is a TMF and an eTMF in clinical trials?

TMF refers to a Trial Master File, which is a clinical document repository. “Documents collected before, during and after a clinical trial prove that the study was conducted, the data collected is correct and valid and that the investigator and sponsor conducted the trial according to ICH GCP guidelines.”

Sponsors and researchers use the Trial Master File in all stages of the clinical study - all activity is documented in the TMF. This means that the TMF could be used to independently recreate the study. To ensure the efficacy of the system, Good Clinical Practice (GCP) has created a list of “essential documents” that researchers and sponsors must collect and store before the clinical phases begin, during the conduct of the clinical trials and after completion.

In short, TMF allows the documentation of all clinical study information, and enables the study to be recreated independently.

TMF documentation is available in paper, electronic (eTMF), or hybrid formats. An “electronic trial master file” is a software solution with the same purpose as the TMF, but in digital format (plus some additional capabilities). While a paper based TMF documentation system is available and widely used, more pharmaceutical companies are integrating an electronic system to improve accuracy, and efficiency.

eTMF vs. CTMS

Clinical Trial Management Systems (CTMS) are a type of software used to manage clinical trials. It is a central end-to-end solution for managing all aspects of a clinical trial from study start-up to close-out across multiple sites.

The CTMS can be integrated with various tools for contact management, monitoring, project planning, reporting and other aspects of the trial. An eTMF and CTMS can also be integrated, making the same content available in both systems in real-time - this integration enables documents to be filed away from one integrated system. Integrating a CTMS with an eTMF can be great for users as it reduces the amount of system-switching required.

So, while a CTMS is a broader software solution that manages and tracks the entire clinical trial process, an ETMF specifically focuses on the management of the trial master file.

Why is an eTMF important and what are some of the benefits?

Using a TMF, whether it be paper-based or electronic, is required under the GCP and it also has many benefits for clinical trials. We’ll go through just some of the benefits below:

Enhanced Collaboration, Document Tracking, and Accessibility: The eTMF centralizes all clinical trial information in a digital format, allowing for seamless tracking, sharing, and access to important documents and data. This enhances collaboration between stakeholders, including sponsors, investigators, and regulatory authorities, as they can access the information they need at any time and from any location.

Improved Regulatory Compliance and Inspection-Readiness: With an eTMF, clinical teams can ensure that all documentation is in compliance with regulatory requirements and easily access up-to-date and accurate information. This reduces the risk of regulatory non-compliance and improves inspection-readiness for the trial.

Increased Data Security and Quality: An eTMF provides enhanced data security through the use of encryption and other security measures to protect sensitive information from unauthorized access and potential breaches. The standardized and organized storage of information in an eTMF also minimizes the risk of manual errors and improves data accuracy, ensuring the quality of the clinical trial data.

eTMF Vendors: Tips for choosing an eTMF system

As reviewed above, an eTMF offers many benefits. There are many vendors who offer an eTMF solution and each system offers different features. Below are several factors you might consider to ensure that you choose the right eTMF system that matches the specific needs of the clinical trial.

Features

Each clinical trial has a unique set of requirements. What is the feature set that is going to meet your needs? Here are some common features that you might look for in an eTMF:

  • A three-folder organization for the TMF structure
  • Compliance with DIA Reference Model
  • An electronic Investigator Site File (eISF) that facilitates the exchange of documents between sites
  • Integration with your CTMS
  • Tools for archival and download of documents
  • Proper visualization of data and performance

Compliance with regulatory requirements

If the eTMF will be used to keep track of regulated documents, the eTMF system will need to be compliant with all relevant regulatory requirements, such as 21 CFR Part 11, GCP, and the ICH guidelines.

Document management and tracking

The eTMF system should provide robust document management and tracking capabilities, including version control, document approval workflows, and document retention policies. Are there customizations you require like custom fields so that the eTMF can be integrated into your workflow more effectively? These are important requirements to think through before selecting a vendor.

Support team

While it is important to find an eTMF platform that is easy to navigate and use, it is also essential to find a good support team that can help you with requests. You might require support for integrating and customizing your eTMF platform on multiple sites, and the eTMF vendor should offer comprehensive and remote support from an eTMF specialist. The support includes training the IT department on the platform, helping solve related issues, and ensuring data security and regulations compliance. The eTMF vendor should also continue to support you after the training and integration and be able to reply quickly to customer feedback.

Here are some leading eTMF vendors:

  • Veeva Vault eTMF: Founded in 2007, Veeva is one of the leading eTMF providers that has helped over a thousand life science companies bring new medicine and treatment to patients. Veeva has been featured in the “Fortune Future 50” and “Forbes Fast Tech 50.”
  • Trial Interactive eTMF: Trial Interactive's eTMF platform features “on-demand TMF experts and award-winning user experience”. The eTMF software includes various features, including real-time collaboration, fast implementation, compliance with safety regulations, audit and inspection readiness, and more. With over 20 years of experience supporting clinical research, Trial Interactive remains one of the top eTMF providers.
  • Medidata Rave eTMF: Medidata’s Rave eTMF is an innovative approach towards simple and fast document management. Unlike other TMF systems, the eTMF allows for “easy integration and implementation within eight weeks”. The system consists of features such as CTMS site monitoring, regulatory tracking, report monitoring, and cloud storage.

Conclusion

In conclusion, an electronic trial master file (eTMF) is a beneficial tool for managing and organizing the documentation and data required to conduct clinical trials. When choosing an eTMF, it is important to consider the features of the system, as well as ensuring the system is compliant. The right eTMF system can help streamline clinical trial operations and improve the overall quality of the trial. By investing in an eTMF system, organizations can ensure that their clinical trials are well-organized, compliant with regulatory requirements, and secure.

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