Source Document

Source documents are original documents containing medical information regarding the subject which are used in the trial. It acts as a tool that confirms the eligibility criteria of the subject. It can include medical records of the subject before, during, and after the trial, and maybe in the form of data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.).

The source document should allow an independent observer to reconfirm data used in the trial and should be able to permit audits and investigation of the trial as required.

Source: Bargaje, C. (2011). Good documentation practice in clinical research. Perspectives in Clinical Research, 2(2), 59.