When a system validation test fails during Electronic Patient-Reported Outcome (ePRO) system testing, the validation documentation must record the expected results (what should have occurred) and the actual results (what occurred).
According to the GCDMP (Chapter: Database Validation and Testing), proper system validation documentation ensures traceability, reproducibility, and compliance with FDA 21 CFR Part 11 and ICH E6 (R2). Each test case must include:
Test objective,
Preconditions,
Test steps,
Expected results,
Actual results, and
Pass/fail status.
If a test fails, this documentation provides the objective evidence necessary for deviation handling, issue resolution, and re-testing. While a separate root cause analysis may be performed later (option D), the validation record itself must focus on verifying outcomes against predefined expectations.
Therefore, the correct answer is B - Expected and actual results.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Validation and Testing, Section 4.4 - Documentation of Test Results FDA 21 CFR Part 11 - Validation Requirements (Section 11.10(a)) ICH E6 (R2) GCP, Section 5.5.3 - Computer System Validation and Documentation