Clinical and regulatory

Good Clinical Practice (GCP) interview questions

Ethical, scientific and quality expectations for clinical trials.

6 questions, each with a worked answer

Why is informed consent essential in clinical research? Fundamentals Concept
What should happen after a protocol deviation is detected? Intermediate Scenario
What is the difference between protocol compliance and participant protection? Intermediate Concept
What can trigger the need for reconsent during a study? Advanced Concept
What data and processes are critical to trial quality by design? Advanced Concept
How would you respond to inconsistent source and eCRF data? Intermediate Scenario

About Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, running, recording and reporting clinical trials. It is set out in ICH E6 and protects participants' rights, safety and wellbeing while keeping trial data credible. It defines the responsibilities of sponsors, investigators and ethics committees, and expectations such as informed consent and monitoring.

Everyone who works on a trial is expected to know it.

Fundamentals: 1
Intermediate: 3
Advanced: 2

What these questions test

Protect clinical participants: Apply ethical and quality oversight in clinical study procedures.

References

ICH Guidance Documents. U.S. Food and Drug Administration. fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents.
ema.europa.eu/en/scientific-guidelines/ich-e6-good-clinical-practice.

Practice material written by TheBench.Bio and checked against the references above, reviewed October 23, 2026. Written to practise with, not collected from real interviews.