Stage-I: Documentation in clinical trials

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Dear Participants,

Welcome back.......................

In continuation to my previous topic..........

Source documents

Source documents are the original documents, data and records collected in a trial. Ex: hospital records, clinic 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.

Tarun Wadhwa