What counts as source data?

Source data is the first record of an observation in a clinical trial, such as a vital sign or a medical finding. With eSource, that first record is made in an electronic system rather than on a paper worksheet. Whether it's on paper or electronic, it's expected to follow ALCOA principles: attributable, legible, contemporaneous, original and accurate.

eSource vs paper source

  • Completeness: electronic forms can flag missing fields, while paper relies on someone noticing
  • Corrections: an audit trail records changes, while paper relies on a handwritten correction
  • Access: records can be reached without finding a binder
  • Continuity: paper still works in an outage, so an eSource site needs a backup plan
  • Cost: eSource has software and training costs, while paper has printing, storage and staff time

One 2023 study published by ACRP found fewer protocol deviations with eSource than with paper. It was a small study, and its authors had ties to an eSource vendor, so treat it as encouraging rather than conclusive.

eSource vs EDC

EDC usually refers to the sponsor's system for collecting study data from all sites. eSource is where the site first records what happened. Without an integration between them, site staff transcribe the required data from source into EDC.

Before you move from paper

  • Ask each sponsor whether it accepts your eSource system
  • Decide who builds and approves templates for each protocol
  • Write down how you'll handle outages and corrections
  • Plan how monitors will access records
  • Start with one study, then expand

See it in practice

PAS OneCore's eSource builds templates from the schedule of activities, keeps a reason for every amendment, and prints blank worksheets for outages.