Q: 15
During testing of an ePRO system, a test fails. Which information should be found in the validation documentation?
Options
Discussion
Probably B. Validation docs are supposed to log the expected and actual results, that’s the main evidence of what happened during testing. D is tempting but root cause isn’t always in initial validation records.
Seriously, every vendor words this stuff differently. For these exam questions, it's B since validation docs always show expected vs actual results to document test outcomes. Not root cause, just what actually happened.
Hmm not totally sure, I think D? Someone confirm?
B , official guides and practice exams always point to expected vs actual results in the validation docs.
I don't think it's D. The trap here is to focus on the investigation rather than what the validation documentation actually records. Documentation needs to show exactly where the test diverged from expectations, so B (expected and actual results) fits better. Root cause comes after, not at this stage. Pretty sure that's what guidelines like GAMP 5 want, but correct me if you read it differently!
I’ve seen similar questions in official practice tests - validation docs always highlight the expected results compared to what actually happened in the test. Extra steps like root cause analysis or training usually come later, not right after a test fails. I think it’s B, but curious if anyone’s study guides say otherwise?
Its B here. Had something like this in a mock and the validation docs always showed expected vs actual results after a failed test. You don't see root cause or training stuff right away. Agree?
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