- For use of this term in accounting, see .
A
source document is a document in which data collected for a clinical trial is first recorded. These data are usually later entered in the
case report form. The
ICH-GCP guidelines define source documents as "original documents, data, and records." Source documents contain source data, which is defined as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial."
