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Consent Withdrawal — SCE Medical Oncology MCQ

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ModerateClinical Trials & StatisticsConsent WithdrawalSCE Medical Oncology

A patient enrolled in a randomised oncology trial withdraws consent and requests all their data be deleted. Under the trial protocol and GCP guidelines, what happens to data already collected?

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Correct answer: C — Data already collected can typically be retained for analysis if the consent form permits; no further data collection occurs from that participant

Under GCP (ICH E6) and UK trial regulations, participants have the right to withdraw consent at any time without penalty. However, data already collected up to the point of withdrawal can usually be retained and used in the analysis if the original consent form permitted this (most modern consent forms include this provision). No further data collection occurs. The participant should be removed from any active treatment protocol. This prevents bias from selective data deletion while respecting autonomy.

Reference: JRCPTB Medical Oncology Curriculum; ICH E6 GCP; UK Policy Framework for Health Research Ethics