Understanding eSource In The New Era Of Clinical Trial Design

By Jennifer Price, John Bunch, and Ryan Kennedy

Today’s clinical trial dashboards alert sponsors and sites to any developing data trends, highlight compliance issues, and provide insight to all study data, including lab and sensor data. This type of immediate alerting and reporting is available when collecting all data close to real time. The FDA defines electronic source data (eSource) as electronic source data initially recorded in an electronic format¹. In decentralized clinical trials (DCTs) today, the participants do not visit the clinic or site for research-related data collection. The patient data is gathered electronically from a variety of sources that don’t need to be transcribed, verified, and double-checked. The participant may need to visit a lab or imaging center, and the resulting data from those facilities ends up in a DCT platform dashboard, in almost real-time.

This industry has been historically slow to adopt any change in existing methodology due to the complexity of adding new processes, new SOPs, providing training, and using a new technology. COVID-19 has pushed the industry into the digital age with the increased use of telehealth, virtual visits, data collected electronically by ePRO, electronic surveys and data provided directly by home health providers.