Source Data Verification (SDV)

What is source data verification? 

Source data verification (SDV) is the process of confirming the accuracy and completeness of data collected during a clinical trial or research study. It involves cross-checking the raw data recorded in the study’s source documents (e.g., patient charts, laboratory reports) with the corresponding data entered into the clinical trial database. SDV ensures that the data used for analysis is reliable, accurate, and compliant with regulatory standards. 

Why is source data verification important? 

Source data verification is vital for ensuring the accuracy, integrity, and regulatory compliance of clinical trial data. By verifying the accuracy of source documents against entered data, SDV helps protect against errors, enhances the reliability of trial results, and supports regulatory approval processes.