임상시험 방법, 수행, 결과, 임상시험 관련 요소, 조치 등을 기술하는 모든 종류의 기록

All records, in any form (including, but not limited to, written electronic magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial, and the actions taken.