How eISFs and eTMFs Can Help Australian Clinical Trials

According to MTPConnect, the Australian clinical trial industry has produced 6,900 new jobs since 2015 and will continue to grow in the future. The Therapeutic Goods Administration encourages this growth with investigator-friendly practices, like letting Human Research Ethics Review Committees take responsibility for sending documents to the TGA. 

But even with these advantages, clinical trials get slowed down by documentation. Research teams waste time printing, faxing, and signing paper forms, while sponsors must travel to sites and dig through enormous binders just to check on a few documents. These problems become even more complex when multiple research centres participate in a study. 

An Electronic Investigator Site File (eISF) and Electronic Trial Master File (eTMF) can solve some of these issues by storing all of your documents online, helping you automate your workflows, and connecting sponsors and research sites remotely. But before you invest in these systems, you may want to know whether eISFs and eTMFs are worth the money, how they differ from each other, and whether they can work together.

Benefits of eISFs and eTMFs

An integrated eISF and eTMF application can help sponsors, HRECs, and research sites work more efficiently. Some of the most common benefits of eISFs and eTMFs include: 

• Saving time: Florence Healthcare estimates that sites create and manage documents up to 40% faster when they have an eISF. 
• Less risk of losing documents: With an eISF, documents won’t end up misplaced, illegible, or damaged.
• Easier monitoring: Virtual access to documents lets sponsors and HRECs monitor studies without having to travel to the research site every time. 
• Successful multi-centre research: An eTMF with remote access to sites’ eISFs makes it easy to keep multiple research sites aligned during a clinical trial. The sponsor can ensure all sites use standard forms and folder structures and can keep an eye on multiple sites’ progress remotely. 

But even if you see the benefits of managing clinical trial documents online, you may wonder whether you need an eISF, an eTMF, or both. Let’s dive into the capabilities of each.

eISF vs. eTMF: What’s the Difference?

Both eISFs and eTMFs manage the regulatory documents and workflows you need to conduct a clinical trial. However, the eISF handles study documents at a single research site, while the eTMF consolidates documents from all the research sites taking part in a study. 

With an eISF, research sites can manage document workflows, sign documents electronically while following compliance guidelines, and store a wide range of content, including regulatory documents and electronic logs.

An eTMF holds essential documents for the entire study, including those obtained from each of the individual research sites’ eISFs. The eTMF allows the TGA and other international regulatory bodies to reconstruct and evaluate the sponsor or sponsor-investigator’s study.

Connecting the eISF and eTMF: Why You Need Both

Through the lens of modern clinical trial operations, you don’t want a completely disconnected eISF and eTMF. That means research sites will have to upload documents to one electronic system, then turn around and download, email, or upload those same documents to another system so sponsors/sponsor-investigators and HRECs can view them. Worse, you may find that many research sites still rely on paper-based, manual processes that stop you from maximizing your eTMF technology. 

One way to solve this problem is through a third-party integration. For example, you might opt to use Florence eBinders™ as the eISF at your research site, but some of your sponsors may already use eTMFs from different companies. You could set up your eBinders™ permissions so that the sponsor or HREC can view and download documents from the eISF system. This lets your sponsor and HREC monitor you remotely and access the documents they need for the eTMF. 

However, there are distinct advantages to using a single natively integrated eTMF and eISF. Using an integrated eTMF and eISF from one provider streamlines documentation, task management, and access across research sites, sponsors or sponsor-investigators, and regulatory authorities. Using one platform also helps multi-centre research studies. The sponsor can set up standard folder structures and templated forms and monitor multiple sites’ productivity, milestones, and essential documents from one place.

If you opt for this method, you need to make sure your eTMF incorporates extensive permission controls. Users should have individual logins with specific permissions based on their role so that they can only view, edit, or sign the documents they’re meant to see. If you’re looking for an eTMF and eISF solution, you’ll definitely want to ask about permission controls and other features that ensure privacy and ICH GCP compliance.

Compliance for eISFs and eTMFs

To satisfy the Human Research Ethics Review Committee, sponsors, and the Therapeutic Goods Administration, your eISF and eTMF need to follow Good Clinical Practice (GCP) standards set by the International Conference on Harmonization (ICH). Because Australian clinical trials must adhere to ICH GCP standards to be accepted within the country and internationally, you’ll need to find a software application that aligns with ICH GCP E6 R2 and the upcoming ICH GCP E6 R3.

Florence Healthcare supports your global compliance by incorporating extensive permission controls so users can only see the documents and data necessary for their role. You can also edit documents to ensure that information is redacted or revealed depending on the permissions a user has. You’ll probably want to ask about features like these when you go to choose an eTMF or eISF for your Australian clinical trials.

What to Look For in an eISF or eTMF

Your eISF or eTMF can make your clinical trial more efficient and more compliant, but the wrong software can slow you down and put you at risk of privacy violations. When looking for an eTMF or eISF, search for software that’s easy-to-use, designed specifically for clinical trials, well-integrated, and fully ICH GCP compliant.

If you’d like to learn more about eISFs or eTMFs, download the Complete Guide to eISF and eTMF, where we frequently discuss these applications and how to get the most out of them for your clinical trial. You can also learn more by visiting this page that outlines additional resources and product functionality.