source documents
source documents
The sum total of the original documents, data and records deemed relevant to a clinical trial.Source documents
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; records kept at the pharmacy, at the laboratories and/or at medicotechnical departments involved in the clinical trial.