Guided Notes
EDC Database Build & User Acceptance Testing
How a study database is specified, built and validated — study design in the EDC, forms, visits, dynamics, roles, integrations, UAT scripts, test data, go-live and post-production changes.
From specification to live database
Slide 1 / 51. Database specification — every form, field, visit, list, dynamic rule and edit check. 2. Build — EDC programmers/builders configure the study. 3. Unit testing by the builder. 4. User acceptance testing (UAT) by data management (and other users) against the specs. 5. Fix and retest defects. 6. Approval and go-live (production) before first patient in. 7. Post-production changes (amendments) follow change control and new UAT.