What is eSource?
Source data is the original record of what happened during a clinical trial visit. eSource means capturing that record electronically rather than on paper. It's different from an EDC, which is usually the sponsor's system for collecting study data from every site.
Built around data integrity
Every amendment records who made the change, when, what the value was and why it changed. Those habits follow the ALCOA+ principles that monitors and auditors look for. In blinded studies, fields such as dose or vaccine lot are withheld from blinded users.
Connected to the rest of the study
A visit can't be saved for a subject without current consent, monitors can verify source with read-only access, and completed visits feed sponsor invoices.