source documents, clinical
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- 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 negatives, 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).
- Used For
- original medical record
- Broader Term
- source documentation
- Related Term
- source data, clinical
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