Source data

Source data is what monitors verify the CRF against. If it is recorded electronically first, the electronic record is the source.

all information in original records, certified copies of original records of clinical findings, observations, or other activities in a clinical investigation (3.8), necessary for the reconstruction and evaluation of the clinical investigation Note 1 to entry: This includes source data initially recorded in an electronic format.

ISO 14155:2020, clause 3.47