Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio; Any untoward or unfavorable…

A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.

An agreement by an individual not competent to give legally-valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research