Definition

A system used to capture and manage clinical trial data electronically, typically via web-based eCRFs with roles and audit trails.

Example

Sites enter visit data in EDC; the system raises validation messages and records every change in the audit trail.

Regulatory source

Common expectations aligned with computerized system controls (Part 11 principles).

Common mistakes

Assuming EDC configuration does not require governance and testing; misconfigured workflows can compromise data quality.

Inspector question

How do you validate and control configuration changes in your EDC during the study?

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