Source document

Hospital charts, lab printouts and device accountability logs are typical source documents. They stay at the site and are kept for the required retention period.

original or certified copy (3.7) of printed, optical, or electronic document containing source data (3.47) EXAMPLE Hospital records, laboratory notes, device accountability records, photographic negatives, radiographs, records kept at the investigation site (3.28), at the laboratories and at the medico-technical departments involved in the clinical investigation (3.8).

ISO 14155:2020, clause 3.48