Managing clinical trial documentation can sometimes feel like juggling hundreds of pieces at once. Ethics approvals, delegation logs, contracts, and training records all need to be filed correctly and kept inspection-ready. Staying on top of everything can be a real challenge.
In every clinical trial, many essential documents must be collected and archived. Essential documents include approvals from ethics committees, study protocols, training logs, contracts with investigators, and many others. Together, these documents form the Trial Master File, or TMF.
Traditionally, TMFs were managed in paper folders, stored on shared drives, or organized through platforms such as SharePoint. The clinical research field is increasingly moving toward digital oversight, and many organizations are moving away from paper-based systems. Inspectors now pay close attention to version control, audit trails, and traceability, which are all areas where an eTMF can add real value. The focus on inspection readiness continues to grow, making a well-organized digital system more important than ever.
An electronic Trial Master File, or eTMF, brings all of this into a secure digital environment, making it easier to store, organize, and manage documents in one place. It can improve efficiency, streamline collaboration, and help ensure compliance. At the same time, implementing an eTMF requires careful planning and preparation to get it right.
If you are considering moving to an eTMF or are unsure how to begin, this blog will guide you through the most important points to consider before taking the next step.
Are you ready for an eTMF?
Before selecting your eTMF and integrating it into your current way of working, it is important to carefully consider the advantages and possible challenges.
An eTMF is often very flexible in its setup and can be tailored to your specific studies and needs. Compared to a paper TMF or a system such as SharePoint, it generally saves time and makes it easier to share the correct and most recent documents with users such as study sites. Access rights can be easily managed and customized. You can decide whether to use Single Sign On or Multi-Factor Authentication, and you can grant access to specific sections so that users only see what is relevant to them. At the end of a study, the entire eTMF can be archived or transferred in one step.
Most importantly, an eTMF is an excellent tool for maintaining compliance with regulatory requirements such as ISO 14155:2020 and the ICH-GCP guidelines for clinical trials. Many systems offer built-in reports, inspection readiness and completeness checks, quality control tools, and reminders for missing documents. They also include an audit trail that records every user's action, ensuring full traceability. Some systems even include tools for monitoring visits, making it easier for site monitors to create and manage their reports.
Time and cost considerations for your eTMF
While the benefits of an eTMF are clear, it is important to consider whether your company is ready for the investment. Depending on the provider and your specific needs, an eTMF solution can be costly. Subscription fees may be high, and system implementation often involves additional one-time costs. In most cases, the eTMF becomes more cost-effective as the number of trials increases. If you only plan to use it for a limited number of studies, an eTMF may not always be the best option.
Implementation also takes time. Setting up a system can take several months, depending on your goals and requirements. You will need a dedicated team to discuss options, make decisions, and establish standards for how the eTMF will be used. Most systems follow the industry-standard TMF Reference Model from CDISC. If you are already familiar with this model, it can make the setup easier. If not, you may choose to adopt it or select a system that allows extensive customization, which may require additional time.
It is also important to plan for the creation of new protocols, work instructions, and supporting tools. Training your team and other end users and giving everyone time to become familiar with the system are essential steps to ensure a smooth transition.
Selecting the right eTMF for your company
Now that you have considered the key points and are ready to ensure compliance and inspection readiness, it is time to explore eTMF providers and see what each system has to offer.
Start by thinking about how user-friendly the system is. Ask for a demo and see how intuitive it feels. Consider your end users, including study sites, and whether they will be able to adopt the system easily. A system that is difficult to navigate can slow adoption and create frustration, so ease of use is essential.
Support and guidance are also important. Consider whether your team can set up the system on its own or whether you will need guidance from the provider during implementation. Also think about ongoing support. Will your team be able to manage user questions internally, or will you rely on the provider’s helpdesk? Having the right support can make a big difference in a smooth rollout.
Integration with other systems is another factor to consider. Can the eTMF connect with tools you already use, such as an Electronic Data Capture System (EDC) to import study data and metrics, or a Clinical Trials Management System (CTMS) to manage trials and monitoring activities? Integrating these systems can save time, reduce errors, and make your studies more efficient. Some providers have all systems included within one environment, which can be a big plus if you are not using any other systems yet but plan to do so.
It is also worth checking how study sites will access the system. Some eTMFs include an electronic Investigator Site File (eISF), while others do not. If your sites are still using paper ISFs, moving to an eISF or a hybrid between paper and eISF can simplify document management and make collaboration much easier.
Next, explore available add-ons and extra features. Options such as Single Sign-On, integration with a study mailbox for easier filing, or built-in tools for document signing and payments can make day-to-day workflows smoother and save time.
Finally, pay attention to the pricing structure. Providers may charge per site, per user, or per trial. Depending on the type and number of studies you run, this can have a significant impact on your budget. Make sure you understand the costs before making a decision.
By reviewing these factors and aligning them with your team’s needs, you will be in a stronger position to select an eTMF system that supports your studies efficiently, securely, and in full compliance with regulatory requirements.
Conclusion
Implementing an eTMF is an important step toward making your clinical trials more efficient, organized, and inspection ready. By carefully considering your team’s needs, the available features, integration options, and budget, you can select a system that truly supports your studies from start to finish.
Choosing the right eTMF can feel like a big decision, but with the right planning and preparation, it becomes a powerful tool for compliance, collaboration, and overall trial management. Whether you are moving from a paper-based system, SharePoint, or another digital solution, an eTMF provides a secure, flexible, and efficient way to keep your trial documentation under control.
For organizations exploring eTMF options, there are several providers on the market that offer robust, user-friendly solutions designed to simplify the transition and support ongoing trial management. Taking the time to evaluate features, support, and integration capabilities will ensure you select the system that best fits your needs and sets your team up for long-term success.