Testing query rules with test data inputs to confirm expected outputs without examining the underlying program logic is an example of black box testing.
According to the GCDMP (Chapter: Data Validation and System Testing), black box testing is a functional testing approach used to verify that the system performs correctly from the end-user's perspective. In this method, testers input various conditions and observe outputs to ensure the system behaves as intended - for instance, that edit checks trigger correctly when data fall outside predefined limits.
In contrast, white box testing involves examining internal logic, code, and algorithm structures. Because data managers typically validate edit checks through data-driven test cases rather than code inspection, black box testing is the appropriate and industry-standard method. This ensures compliance with validation documentation standards as outlined in FDA 21 CFR Part 11, Section 11.10(a) and ICH E6 (R2) system validation expectations.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Validation and Testing, Section 4.1 - Testing Approaches (Black Box and White Box) FDA 21 CFR Part 11 - System Validation Requirements ICH E6 (R2) GCP, Section 5.5.3 - Computerized Systems Validation