What is eSource in clinical trials?

The clinical research landscape has seen lots of innovation over the past decade, and eSource in clinical trials has emerged as a game-changer for data collection and management. By capturing data electronically at its point of origin, eSource eliminates redundant transcription steps, reduces human error, and streamlines the data management process.

Defining eSource

eSource, short for electronic source data, refers to clinical research data originally collected in electronic format, without transcription from another medium.

Traditional data collection usually involves recording patient information on paper or in electronic medical records (EMR) first, then transcribing that information into an electronic data capture (EDC) system.

Take a deep dive into EDC for clinical trials. Learn what it is, how it works, and how it can help you deliver better trial outcomes.

Types of eSource:

Direct Data Capture (DDC)

Electronic systems, specifically designed for the immediate recording of clinical observations during patient visits, such as tablets and mobile apps.

Non-case report forms

Specialized electronic forms outside the standard CRF workflow, including electronic patient diaries, quality of life questionnaires, and digital symptom trackers.

Electronic health records

Data from EMR systems, like digital patient charts, are categorized as eSource when transferred to the clinical trial EDC system through validated software interfaces, creating a certified copy with all metadata.

Devices and apps

Wearable sensors, mobile health applications, and other digital tools that continuously capture data.

The benefits of eSource in electronic data capture

Improved data quality

eSource eliminates errors by removing the extra step of copying data from one place to another. Data checks happen when patients or staff enter information, catching anomalies immediately. This means cleaner data from the offset.

Lower costs

Though setting up eSource requires upfront investment, the savings add up quickly. Fewer errors mean less time spent cleaning data and answering queries. Monitoring is more efficient and focused.

Better for patients

eSource makes clinical trials more patient-friendly. Digital tools allow participants to submit information from home, reducing site visits. This convenience makes joining and staying in trials easier for patients, improving recruitment and retention rates.

eSource vs. EDC: key differences

While eSource and EDC are sometimes discussed as distinct, the comparison is not entirely accurate. eSource originally referred to clinical research data captured electronically at the point of care. In other words, data that hadn’t been transcribed from another format. Over time, however, the definition of eSource has expanded to include the computerized systems used to collect such data. Today, eSource refers to both the originally electronic data and the tools used to capture it.

Modern EDC systems, like Viedoc, support eSource functionality. This means they allow for direct entry of source data at the point of care, making them not only data repositories but also eSource systems.

So, rather than comparing eSource and EDC, it’s more accurate to compare eSource data to transcribed source data, where the key difference lies in the data entry method and associated risks.

With eSource, there’s no need for manual transcription from paper or external systems (like EMRs), reducing the potential for errors and the burden on site staff and monitors. This enhances data integrity and improves overall trial efficiency.

eSource vs. EMR: key differences

Purpose and uses

Electronic medical records (EMR) focus on documenting patient care, whereas eSource systems specifically collect and manage clinical research data.

Data standards

EMRs vary widely in structure and standards, while eSource systems for clinical trials typically adhere to research-specific data standards.

Common challenges in eSource adoption and solutions

Regulatory concerns and solutions

Regulators have provided guidance on eSource implementation, but concerns remain about data integrity and compliance. To mitigate this, introduce thorough documentation of system validations and robust audit trails that track all data changes.

User adoption

Introducing new systems is often met with resistance. Training programs, user-friendly interfaces, and demonstrating time savings can help overcome adoption barriers.

Integration with existing systems

Creating validated interfaces between eSource systems and other clinical trial technologies is sometimes complex. Using systems that support common data standards can simplify these integrations.

Best practices for implementing eSource in clinical trials

Carefully evaluate your study needs: while eSource offers many benefits, it may not be the best fit for all studies. Consider factors like therapeutic area, phase, and protocol complexity.
Choose integrated solutions: look for systems that already integrate with your existing technology stack to minimize custom development.
Focus on user experience: select eClinical software that site staff will find intuitive and easy to use.
Start small: consider piloting eSource in less complex studies before implementing across your entire portfolio.
Monitor the actual savings: track metrics to quantify time and cost savings and evaluate the return on investment.

Unlock the full potential of eSource in clinical research

eSource is undoubtedly transforming electronic data capture in clinical trials, offering substantial benefits in data quality, efficiency, and cost reduction. However, successful implementation requires careful planning, appropriate technology selection, and a clear understanding of the potential challenges. With the right approach, eSource can help accelerate your clinical research while maintaining the highest standards of data integrity.