식품의약품안전처장이 임상시험 관리기준 및 관련 규정에 따라 임상시험이 실시 되었는지를 확인할 목적으로 시험기관, 의뢰자 또는 임상시험 수탁기관 등의 모든 시설‧문서‧기록 등을 현장에서 공식적으로 조사하는 행위

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).