ACRP GCP and Clinical Trial Principles Practice Test

Source data verification means checking that what is written on the Case Report Form matches the original records kept about the participant. In practice, this involves comparing CRF data with source documents such as medical charts, lab reports, imaging results, and other the initial records to confirm accuracy and completeness. This creates a reliable, traceable record that supports data integrity for regulatory submission and auditing.

It’s not about data entry speed, nor about who analyzes the data at the sponsor, nor about restricting verification to adverse events. Those describe different tasks. SDV focuses on the accuracy and consistency of data by cross-checking CRF entries against source documentation, though in modern practice some SDV may be selective under risk-based monitoring.