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- Published
- Updated
- Sources checked
EDC acceptance should demonstrate that the configured study supports real users and meaningful data decisions. Screenshots of successful entry cannot show whether missing values, amendments or restricted roles behave correctly.
Define critical test scenarios
Translate protocol requirements into testable workflows: visit scheduling, repeated assessments, units, investigator review and correction. Rank scenarios by their effect on participant protection and the reliability of study results. Keep vendor platform testing distinct from study configuration acceptance.
Challenge a laboratory form
For a laboratory result, test a permitted value, an impossible unit, an absent result and a corrected result. Record expected behaviour, actual behaviour, user role, build version and evidence. A failed test needs an impact decision, not simply a new screenshot.
EDC release checks
- Trace critical requirements to executed test scenarios.
- Retest corrected defects and affected neighbouring workflows.
- Approve outstanding defects with owner, rationale and restrictions.
Accept the tested build
Release the named build only after accountable reviewers accept the evidence and the production configuration matches the tested configuration. Test new risks introduced by amendments and retain the release decision with the study records. Record test-account privileges and use suitable representative data; unnecessary real participant information should not be introduced merely to make the test look realistic.
Frequently asked questions
- Does supplier validation replace study UAT?
- It can support platform assurance, but the configured study and intended users still need appropriate assessment.
- Must every field receive identical testing?
- Use a documented risk assessment to focus testing while retaining adequate coverage.