The saying “The only constant in life is change” is attributed to the Greek philosopher Heraclitus hundreds of years before clinical study electronic data capture systems, or EDCs, were around to influence that observation. If the concept of developing and maintaining an EDC that minimizes post-release changes is Greek to you, you’re in luck. Over the next two months, Brian Harvey, our manager of clinical data systems will take the podium in our BRIGHT Insights forum and share the BRIGHT philosophy on EDC development and change management.
What is the EDC?
The EDC is a software system that collects and manages clinical trial data in an electronic format. The off-the-shelf system is configured specifically to support each study and its design. Not to be confused with the electronic trial master file, or eTMF, which stores essential regulatory documents such as the study protocol, training records, and agreements, the EDC stores subject data. Subject data includes electronic case report forms (eCRFs), study logs, investigational product accountability, and even safety committee documentation.
Make the first EDC release, the best release
The EDC should, of course, be designed in compliance with FDA guidance, such as Use of Electronic Health Record Data in Clinical Investigations. But compliance is a minimum standard, and we’re going to share some tips to help you optimize your design. So, let’s discuss three aspects of EDC content that, when designed well upfront, get your study off to a solid start and limit the need for unnecessary post-release changes. Note: your EDC work begins AFTER you have a well-established protocol developed; that is, one that incorporates critical inputs from physicians, key opinion leaders, and regulatory bodies.
1. Vetted case report forms = robust design inputs
Before anything happens in the EDC, the first step is to carefully design case report forms. Rather than doing this step in a vacuum, we recommend that you get input from your study end users, such as the following:
- The study lead can confirm the CRF flow aligns with the protocol
- The research coordinator can confirm the CRF flow aligns with the standard-of-care or other procedural considerations at the site
- The data manager or statistician can confirm the right data is being collected in sufficient quantity to be meaningful (no garbage in, garbage out on our watch!)
As each end user runs through CRFs, from screening to study closure, record their impressions and incorporate their feedback into the EDC build drafts. You’ll find this is a great way to figure out what’s going to work or not early in the process, ensuring that your software design is informed by robust inputs.
2. Consider the user to design efficient screen layouts
All good designs begin by considering the needs of the user (often referred to as the end user), and we aim to make their data entry experience as simple and straight-forward as possible. Once the CRFs have been vetted by end users, it’s time to strategically design the visual layout – the screen designs and flows – to ensure intuitive and efficient data entry. When you ace the user interface aspect of EDC design, research coordinators will be seeing hearts instead of stars.
Our preferred EDC layout presents the users with a single screen dashboard view of all required CRFs for the selected study subject. Maintaining as much consistency as possible with the protocol provides a familiar starting point for the users, so we present this dashboard as a visit grid that looks similar to the protocol table of assessments. We also use embedded logs to create intuitive pathways that allow users to drill down into a specific CRF or follow-up visit without having to flip between multiple screens.
3. Test user access and functionality for every study role
Your carefully crafted EDC is almost ready to roll, but not before a thorough round of user access and functionality testing. You can have the best system content in the world, but if the research coordinators can’t randomize a subject, monitors can’t review data, and the core lab can’t do data entry for their specific CRFs, yeah, you get it.
All users in the system will be assigned a study role that allows them access to enter or simply view data, depending on what’s needed in that role (e.g., research coordinator, investigator, monitor, data manager, safety committee member, and core lab personnel). Some users may be assigned multiple roles. This stage of design requires a thorough process to carefully test the data flow, from subject screening to study closure, to ensure every user role will have the appropriate type of access for each of the actions they need to complete. Consider creating a test user name that has access to all the roles so that your email inbox will not be flooded when system notification functions are tested.
Not only is this a great practice to ensure EDC feasibility and usability, it’s also in the regulations. While many off-the-shelf EDC systems are designed to be 21 CFR Part 11-compliant, it’s only until you configure, validate, and test your custom-designed system against these requirements that true compliance can be achieved. A common failure point here is that testers often stop with site data entry. A Part 11-compliant EDC ensures the data can be reviewed, cleaned, and processed in a timely and meaningful way by the appropriate users, and many of these steps occur well after initial data entry.
The EDC is a powerful clinical software tool that requires purposeful initial design and, as we’ll discuss next month, careful maintenance throughout a study. A solid initial release – based on robust design, user-focused screen layouts, and robust user access and functionality testing – will get your study started and get your end users acclimated to the data entry process. But, like all software, there is an expected level of impermanence to its existence. Embrace this eventuality and put your best foot forward on the initial release to minimize unnecessary or painful post-release changes.
Can’t wait for next month’s post? Pop over to the BRIGHT Insights archives and read Case Report Forms: The 5 C’s of Good Design. These tips will also help get your EDC off on the right foot.