Clinical Research Terms Glossary

Source Data

Source data is all information (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, study participant diaries, recorded data from automated instruments, x-rays, etc.) pertaining to the clinical findings, observations, or other activities from a clinical study. They are located in original records and certified copies of original records (source documents) that can be used to reconstruct and evaluate a study. (CDISC)