Source Data Verification (SDV) is a quality control procedure in clinical trials where the data recorded in the Case Report Forms (CRFs) or electronic data capture (EDC) system are compared directly against the source documents to ensure accuracy and completeness. Source documents refer to the original records and certified copies of clinical findings, observations, or other activities in the trial. Examples include hospital records, lab reports, physician notes, and original informed consent forms.
The SDV process is typically performed by the clinical monitor or a qualified auditor from the trial sponsor (e.g., a pharmaceutical company) during monitoring visits. By verifying the data’s integrity, SDV is essential for ensuring adherence to the trial protocol and compliance with Good Clinical Practice (GCP). While traditional SDV involved checking every data point (100% SDV), the trend is now shifting towards risk-based monitoring, where verification efforts are focused on critical data points and areas with high potential for error, leveraging technology and Real-World Data (RWD) analysis to improve efficiency and maintain data quality.
