Query rules were tested with test data for each logic condition within each rule.

Testing query rules withtest data inputs to confirm expected outputswithout examining the underlying program logic is an example ofblack box testing.

According to theGCDMP (Chapter: Data Validation and System Testing), black box testing is afunctional testing approachused 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 testinginvolves 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 testingis the appropriate and industry-standard method. This ensures compliance with validation documentation standards as outlined inFDA 21 CFR Part 11, Section 11.10(a)andICH 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