ICH E6(R3) – The act of overseeing the progress of a clinical trial and of ensuring that the clinical trial is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirement(s).
CDISC-Gloss – Act of overseeing, tracking, observing, evaluating or supervising over time by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring, data monitoring, risk-based monitoring.