How eSource and EDC Benefit Your Trials

The use of digital tools in clinical trials has skyrocketed in recent years, with more and more researchers incorporating remote visits, real-world data, and surveys from patient devices into their trial design. But the industry terms used to describe digital tools can get confusing quickly. eConsent, eSource, eCOA, ePRO, eCRF, EDC—it all starts to blend together.?

These similar-sounding terms have distinct meanings with unique implications for each clinical trial. Here we’ll dive into the differences between electronic source (eSource) data and electronic data capture (EDC) systems, their advantages and challenges, and how to choose the best data capture tools for your clinical trial.?

Defining eSource and EDC

According to the FDA, eSource data is “data initially recorded in electronic format.” eSource data includes original records of activities used in clinical research (findings and observations) regulators can refer to when evaluating the investigation.

Experts divide eSource into four categories: direct data capture, non-case report forms, electronic health records, and devices and apps (Figure 1). Note that eSource is not only data entered directly into a computer. eSource also includes medical records, lab reports, survey answers, and consumer wearables. Anything that originates digitally and is used to create evidence is eSource.?

While eSource refers to a type of data, EDCs are software programs that store data electronically. Site personnel may enter data directly into EDCs, but often the data is transcribed from paper forms by CROs, investigators, or sponsors. Data entered into EDCs resides in electronic case report forms (eCRFs) custom-built for trial endpoints.?

How eSource & EDCs benefit clinical trials

The structure built into EDCs simplifies comparing and analyzing trial data. However, re-entering data into EDCs can be a major burden for staff and leaves opportunities for transcription errors. eCRFs also do not automatically collect supplementary data that may help researchers better understand how a treatment works in the real world.?

eSource places less burden on site staff and reduces chances of error, making for higher quality data with higher traceability. It also can be used to form conclusions about a therapy’s real-world effectiveness. However, using eSource requires integrations like application programming interface (API) software to move data from an outside source into a trial database. And using eSource to establish endpoints requires additional work in the trial design to ensure it is fit for purpose.??

Choosing between eSource and an EDC

EDCs: A basic function

Most trials require EDCs to make patient data usable. Researchers manage patient data from EDCs in a centralized hub, allowing them to see statistics as studies move along, track progress, resolve problems, make mid-study modifications, and validate data. EDCs are a basic function of a modern clinical trial.

eSource: When remote components matter

But many studies can benefit from additional data. This is especially true for studies that must use data from third-party electronic health record systems or rely heavily on remote data capture, such as data from wearables.?

Take RSP Systems, for example. They needed to capture multiple measurements from their non-invasive glucose monitoring device, GlucoBeam, used in patients’ homes. Manually copying data from each device into a database would take enormous time and people-power. Instead, they used API integration to move data directly from devices into the trial database, saving time and giving them controlled access to their study data.?

Direct Data Capture (DDC) eSource

Direct Data Capture (DDC) eSource involves the immediate electronic capture of data, which eliminates the need for paper-based data collection and subsequent transcription. This method is known to enhance efficiency without compromising data quality. In fact, it often leads to improved data quality due to the reduction in transcription errors and the real-time availability of data for review and decision-making.

The FDA's guidance on electronic source data in clinical investigations underscores the importance of DDC eSource, emphasizing its role in ensuring data's reliability, quality, integrity, and traceability?in clinical trials. The European Medicines Agency (EMA) has also endorsed using DDC eSource, citing its potential to streamline clinical trial processes.

According to the EMA's guidance, the implementation of DDC eSource has led to a six-fold decrease in the time to data availability, a 7% increase in the number of data points remaining unchanged throughout the study, and a more than 50% reduction in the time to resolve data queries. These metrics highlight the efficiency and quality improvements brought about by DDC eSource in clinical trials.

Data ecosystems provide options for both eSource and EDCs

Thankfully, researchers don’t have to choose between eSource and an EDC system because clinical trial software often offers opportunities for both. eSource and EDCs can have complementary functions within a study’s data ecosystem. Some solutions manage all their data with a clinical trial data management system (CDMS). Others integrate EDCs and eSource data into interconnected decentralized clinical trials (DCT) modules.?

When considering software for your clinical trial, consider what you need most and the integrations you expect to use. Better yet, choose software with what you need now and options to add integrations as your study progresses. But the first step is to know the differences between the available tools. Now you can check that off your list.??

Still have questions about eSource? Visit our solution page to learn more about successfully implementing new technology to your trial workflow, including eSource. ?