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Electronic Source (eSource)

What is eSource? eSource is a digital system that allows for initial data capture in an electronic source. This can be in the form of electronic consent forms, electronic patient diaries, electronic case report forms (eCRF), and clinical outcomes.

What are the benefits of using eSource?

The use of eSource has brought several benefits to the clinical trial process, including:

  • Increased efficiency as duplicate forms do not need to be filled, paper forms do not have to be scanned, and the forms can be monitored remotely through integration with other software.
  • Decreased risk of transcription errors.
  • Increased reliability, quality, integrity, and completeness of data.
  • Allowing near real-time monitoring for adverse events, risks to patients, and potential errors in data.
  • Increased possibility to run clinical trials on a global scale.
  • Safer and more efficient retention of records.

Source: US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), & Center for Devices and Radiological Health (CDRH). (2013, September). Guidance for Industry | Electronic Source Data in Clinical Investigations. USFDA. https://www.fda.gov/media/85183/download