When a system validation test fails duringElectronic Patient-Reported Outcome (ePRO)system testing, thevalidation documentationmust record theexpected results(what should have occurred) and theactual results(what occurred).
According to theGCDMP (Chapter: Database Validation and Testing), proper system validation documentation ensurestraceability, reproducibility, and compliancewithFDA 21 CFR Part 11andICH 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 separateroot cause analysismay be performed later (option D), the validation record itself must focus on verifying outcomes against predefined expectations.
Therefore, the correct answer isB – 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