skip to main content

Clinical Trial Protection UK — SCE Medical Oncology MCQ

Instant feedback + full explanation. One question, done properly.

EasyClinical Trials & StatisticsClinical Trial Protection UKSCE Medical Oncology

A 65-year-old woman with cancer is starting a clinical trial. She asks about what happens if she is harmed by the experimental treatment. What protection exists in UK clinical trials?

Educational content. Not a substitute for clinical judgement or local policy.

Reveal the answer and explanation

Correct answer: D — UK clinical trials must have: appropriate indemnity/insurance, ethics committee approval (REC), informed consent including discussion of risks/compensation, MHRA authorisation for CTIMPs, and duty of care from the research team — the Association of the British Pharmaceutical Industry (ABPI) guidelines provide a no-fault compensation scheme for industry-sponsored trials

UK clinical trial participant protections: REC approval (mandatory), MHRA authorisation for CTIMPs, informed consent (GCP), appropriate indemnity (NHS indemnity for NHS-sponsored trials; ABPI no-fault compensation for industry trials), duty of care, right to withdraw without penalty, data protection. These protections are enshrined in the UK Medicines for Human Use (Clinical Trials) Regulations 2004 and ICH E6 GCP.

Reference: JRCPTB; UK Clinical Trials Regulations; ICH E6 GCP; ABPI Guidelines