Source documents

Original documents, data, and records involved in the clinical trial (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participants’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, participant files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments). ICH GCP, 1.52