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Clinical trial serious adverse event reporting — MRCPCH TAS MCQ

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HardEthics, law and research governanceClinical trial serious adverse event reportingMRCPCH TAS

A child in a blinded drug trial is admitted with an unexpected life-threatening arrhythmia. The investigator suspects a possible relation to the study medicine. What is the most appropriate research governance action?

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Correct answer: B — Report as a suspected serious adverse reaction through trial safety pathways

An unexpected life-threatening event possibly related to the trial medicine requires urgent reporting through the trial's pharmacovigilance and sponsor pathways. Waiting until database lock would delay safety oversight. The pearl is that research governance aims to protect current participants while preserving trial integrity where possible.

Reference: UK Health Research Authority guidance; Good Clinical Practice principles; RCPCH Theory examination syllabi