병원 기록‧의무기록‧피험자기록‧메모‧병리검사결과‧피험자일기 또는 평가 점검표‧약국의 의약품 불출 기록‧자동화 검사 기기에 기록된 자료‧검사인증서 및 공식 사본‧마이크로피시‧마이크로필름‧방사선학적 검사자료‧자기테이프‧약국 기록자료‧병리검사실 기록자료 등과 같이 근거자료를 담고 있는 모든 문서‧자료‧기록

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Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negative, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).