In Electronic Data Capture (EDC) system validation, User Acceptance Testing (UAT) is a mandatory phase that must be completed before data collection begins in the production environment.
According to the GCDMP (Chapter: Database Design, Validation, and Testing) and FDA 21 CFR Part 11, UAT ensures that the EDC system meets all protocol-specific, functional, and regulatory requirements before it is deployed for live use. The goal is to verify that the system performs exactly as intended by simulating real-world user interactions with test data in a validated test environment.
Data collection prior to UAT completion would violate validation requirements and risk noncompliance with ICH E6 (R2) GCP Section 5.5.3, which mandates that all computerized systems be validated and tested before use.
While options A and C describe correct components of testing strategy, the key regulatory requirement is that UAT must be completed and approved before live data entry begins. Option D is incorrect - risk-based UAT is an accepted modern validation approach under both FDA and GAMP5 principles.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Validation, Section 5.3 - User Acceptance Testing FDA 21 CFR Part 11 - Validation of Electronic Systems (Section 11.10(a)) ICH E6 (R2) GCP, Section 5.5.3 - Validation Before Use in Production Environment