임상시험 진행 과정을 감독하고, 해당 임상시험이 계획서, 표준작업지침서, 임상시험 관리기준 및 관련 규정에 따라 실시‧기록되는지 여부를 검토‧확인하는 활동

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).