What is source data verification and why is it important in clinical research?

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Source data verification is the process of verifying that data recorded in case report forms match the original source documents, such as medical records, lab results, and signed consent forms. This step is essential because it safeguards data integrity—ensuring each data point reflects what actually occurred with the patient—and it provides a reliable basis for safety monitoring, efficacy assessment, and regulatory review. By identifying and correcting transcription errors, omissions, or inconsistencies, SDV helps ensure trial results are accurate and credible and that there is a clear, auditable trail for inspections. In practice, SDV may cover all data or focus on high-risk, critical data fields using a risk-based approach. It is a separate activity from data security measures like encryption, budgeting tasks, or randomization.